A Randomized Trial to Prevent Congenital Cytomegalovirus... | NCT01376778

ID	Type	Link
U10HD036801	U.S. NIH Grant/Contract	View source
U10HD027869	U.S. NIH Grant/Contract	View source
U10HD027915	U.S. NIH Grant/Contract	View source
U10HD034116	U.S. NIH Grant/Contract	View source
U10HD034208	U.S. NIH Grant/Contract	View source
U10HD040500	U.S. NIH Grant/Contract	View source
U10HD040485	U.S. NIH Grant/Contract	View source
U10HD040544	U.S. NIH Grant/Contract	View source
U10HD040545	U.S. NIH Grant/Contract	View source
U10HD040560	U.S. NIH Grant/Contract	View source
U10HD040512	U.S. NIH Grant/Contract	View source
U10HD053097	U.S. NIH Grant/Contract	View source
U10HD068282	U.S. NIH Grant/Contract	View source
U10HD068258	U.S. NIH Grant/Contract	View source
U10HD068268	U.S. NIH Grant/Contract	View source
UG1HD087230	U.S. NIH Grant/Contract	View source
UG1HD087192	U.S. NIH Grant/Contract	View source

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Label	Type	Description	Intervention Names
CMV hyperimmune globulin - Cytogam®	Active Comparator	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)	Drug: CMV hyperimmune globulin
Placebo	Placebo Comparator	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
CMV hyperimmune globulin	Drug	The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.

Measure	Description	Time Frame
Number of Participants With the Composite Primary Outcome	The primary outcome is a binary outcome defined by the occurrence or non-occurrence of any of the following vs. none of the following: fetal loss (spontaneous or termination), confirmed fetal CMV infection from amniocentesis, neonatal death before assessment of CMV infection can be made, or neonatal congenital CMV infection. Neonatal congenital CMV infection is diagnosed by urine or saliva collected by 3 weeks of age that is positive for CMV by culture (the intent will be to obtain in the first two days of life). In the event that Polymerase Chain Reaction (PCR) is positive but culture is negative, a repeat culture must be positive by 3 weeks of age.	From randomization through 3 weeks of life
Number of Participants Who Had a Fetus or Neonate With CMV Infection	Component of composite primary outcome	From randomization through 3 weeks of life
Number of Participants Who Had a Neonatal Death Without CMV Infection	component of composite primary outcome	From randomization through 3 weeks of life
Number of Participants With a Fetal or Neonatal Death With Proven CMV Infection	component of primary composite outcome	From randomization through 3 weeks of life
Number of Participants With Fetal Death Without Proven CMV Infection	component of primary composite outcome	From randomization through delivery

Measure	Description	Time Frame
Number of Participants With Gestational Hypertension or Preeclampsia	Gestational hypertension or preeclampsia is a binary outcome defined by occurrence or non-occurrence of gestational hypertension or preeclampsia. Gestational hypertension or preeclampsia are new onset hypertension during pregnancy	from randomization through discharge from the hospital

Name	Affiliation	Role
Monica Longo, MD	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Study Director
Rebecca Clifton, PhD	George Washington University	Principal Investigator
Brenna Hughes, MD	Brown University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama - Birmingham		Birmingham	Alabama	35233	United States
Stanford University

PubMed Identifier	Type	Citation	Retractions
34320288	Result	Hughes BL, Clifton RG, Rouse DJ, Saade GR, Dinsmoor MJ, Reddy UM, Pass R, Allard D, Mallett G, Fette LM, Gyamfi-Bannerman C, Varner MW, Goodnight WH, Tita ATN, Costantine MM, Swamy GK, Gibbs RS, Chien EK, Chauhan SP, El-Sayed YY, Casey BM, Parry S, Simhan HN, Napolitano PG, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection. N Engl J Med. 2021 Jul 29;385(5):436-444. doi: 10.1056/NEJMoa1913569.
35115450

ID	Title	Description
FG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Nov 1, 2017

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With the Composite Primary Outcome

The primary outcome is a binary outcome defined by the occurrence or non-occurrence of any of the following vs. none of the following: fetal loss (spontaneous or termination), confirmed fetal CMV infection from amniocentesis, neonatal death before assessment of CMV infection can be made, or neonatal congenital CMV infection. Neonatal congenital CMV infection is diagnosed by urine or saliva collected by 3 weeks of age that is positive for CMV by culture (the intent will be to obtain in the first two days of life). In the event that Polymerase Chain Reaction (PCR) is positive but culture is negative, a repeat culture must be positive by 3 weeks of age.

Posted

Count of Participants

Participants

From randomization through 3 weeks of life

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000203 OG001191

Title

Denominators

Categories

Title	Measurements
	OG00046 OG00137

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		0.42		Risk Ratio (RR)	1.17			2-Sided	95	0.80	1.72					Superiority

Primary

Number of Participants Who Had a Fetus or Neonate With CMV Infection

Component of composite primary outcome

Posted

Count of Participants

Participants

From randomization through 3 weeks of life

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Primary

Number of Participants Who Had a Neonatal Death Without CMV Infection

component of composite primary outcome

Posted

Count of Participants

Participants

From randomization through 3 weeks of life

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Primary

Number of Participants With a Fetal or Neonatal Death With Proven CMV Infection

component of primary composite outcome

Posted

Count of Participants

Participants

From randomization through 3 weeks of life

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Primary

Number of Participants With Fetal Death Without Proven CMV Infection

component of primary composite outcome

Posted

Count of Participants

Participants

From randomization through delivery

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Gestational Hypertension or Preeclampsia

Gestational hypertension or preeclampsia is a binary outcome defined by occurrence or non-occurrence of gestational hypertension or preeclampsia. Gestational hypertension or preeclampsia are new onset hypertension during pregnancy

Posted

Count of Participants

Participants

from randomization through discharge from the hospital

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Participants With Placental Abruption

Placental abruption is a binary outcome defined by occurrence or non-occurrence of placental abruption, defined as bleeding and contraction pain

Posted

Count of Participants

Participants

From randomization through delivery (maximum 42 weeks gestation)

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Median Gestational Age at Delivery

Gestational age at delivery in weeks

Posted

Median

Standard Deviation

weeks

Delivery

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Number of Participants Whose Gestational Age at Delivery Was Before 37 Weeks

Gestational age before 37 weeks gestation is a binary outcome meaning occurrence or non-occurrence of delivery before 37 weeks gestation

Posted

Count of Participants

Participants

Delivery before 37 weeks gestation

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Participants Whose Gestational Age at Delivery Was Before 34 Weeks, 0 Days

Gestational age before 34 weeks, 0 days gestation is a binary outcome meaning occurrence or non-occurrence of delivery before 34 weeks gestation

Posted

Count of Participants

Participants

Delivery before 34 weeks gestation

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Participants Reporting Yes or no to Medication Side Effects

Occurrence or non-occurrence of a designated side effect of medication

Posted

Count of Participants

Participants

From randomization (10-27 weeks gestation) through delivery (maximum 42 weeks gestation)

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Had a Fetal or Neonatal Death

Fetal death or death of a neonate born alive

Posted

Count of Participants

Participants

From randomization (10-27 weeks gestation) through delivery (maximum 42 weeks gestation) up to 120 days of life

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Median Neonatal Head Circumference

Neonatal head circumference measured within 72 hours of birth

Posted

Median

Standard Deviation

centimeters

72 hours postpartum

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Median Birth Weight

Birth weight as recorded in the medical record

Posted

Median

Standard Deviation

grams

Delivery

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Fetal Growth Restriction

Fetal growth restriction is a binary outcome defined as the occurrence or non-occurrence of growth restriction (defined as <5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data)

Posted

Count of Participants

Participants

Delivery

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Participants With Symptomatic CMV Infection

Fetal or neonatal symptomatic CMV infection is a binary outcome defined as the occurrence or non-occurrence of symptomatic CMV infection defined as CMV isolated from an amniocentesis, or urine or saliva during the first three weeks of life and at least one of the following: jaundice (with direct bilirubin exceeding 20% of total bilirubin), thrombocytopenia , anemia , hepatitis, hepatomegaly, splenomegaly, growth restriction, failure to thrive, intracerebral calcifications, microcephaly, hypotonia, seizures, petechial rash, hearing loss, interstitial pneumonitis, thrombocytopenia, anemia, hepatitis, chorioretinitis, or CMV in cerebrospinal fluid

Posted

Count of Participants

Participants

During pregnancy up to 3 weeks postpartum

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Secondary

Number of Neonates With Grade 3 or 4 Intraventricular Hemorrhage

Intraventricular hemorrhage (IVH) as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papile classification system. IVH is a binary outcome defined by occurrence or non-occurrence of IVH

Posted

Count of Participants

Participants

0 days to approximately 120 days of life or hospital discharge, whichever is sooner

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Neonates With Ventriculomegaly

Ventriculomegaly is a binary outcome defined by the occurrence or non-occurrence of ventriculomegaly

Posted

Count of Participants

Participants

0 days to approximately 120 days of life or hospital discharge, whichever is sooner

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Number of Neonates With Retinopathy of Prematurity (ROP)

Retinopathy of prematurity is a binary outcome defined by the occurrence or non-occurrence of retinopathy of prematurity, diagnosed by ophthalmologic examination of the retina and a diagnosis of Stage I (demarcation line in the retina) or greater.

Posted

Count of Participants

Participants

0 days to approximately 120 days of life or hospital discharge, whichever is sooner

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Neonates With Respiratory Distress Syndrome

Respiratory distress syndrome is a binary outcome defined by the occurrence or non-occurrence of Respiratory distress syndrome (defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with an oxygen requirement and a chest x-ray that shows hypoventilation and reticulogranular infiltrates).

Posted

Count of Participants

Participants

0 days to approximately 120 days of life or hospital discharge, whichever is sooner

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts

Secondary

Number of Neonates With Chronic Lung Disease

Neonatal chronic lung disease is a binary outcome defined by the occurrence or non-occurrence of chronic lung disease or bronchopulmonary dysplasia (BPD) defined as oxygen requirement at 28 days of life

Posted

Count of Participants

Participants

28 days of life

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Neonates With Necrotizing Enterocolitis (NEC)

Necrotizing enterocolitis (NEC) is a binary outcome defined by the occurrence or non-occurrence of NEC, defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation.

Posted

Count of Participants

Participants

0 days to approximately 120 days of life or hospital discharge, whichever is sooner

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts

Secondary

Number of Neonates With Hyperbilirubinemia

Hyperbilirubinemia is a binary outcome defined by the occurrence or non-occurrence of hyperbilirubinemia. Peak total bilirubin of at least 15 mg% or the use of phototherapy

Posted

Count of Participants

Participants

From birth to 1 week of life

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Neonates With Suspected Neonatal Sepsis

Suspected neonatal sepsis is a binary outcome defined as the occurrence or non-occurrence of suspected neonatal sepsis

Posted

Count of Participants

Participants

0 days to approximately 120 days of life or hospital discharge, whichever is sooner

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Neonates With Neonatal Pneumonia

Neonatal pneumonia is a binary outcome defined as the occurrence or non-occurrence of neonatal pneumonia

Posted

Count of Participants

Participants

0 days to approximately 120 days of life or hospital discharge, whichever is sooner

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Number of Neonates Experiencing Seizures / Encephalopathy

Neonatal seizures/encephalopathy is a binary outcome defined as the occurrence or non-occurrence of seizures/encephalopathy

Posted

Count of Participants

Participants

0 days to approximately 120 days of life or hospital discharge, whichever is sooner

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Median Length of Neonatal Hospital Stay

Length of hospital stay, need for Neonatal Intensive Care Unit (NICU) or intermediate care admission and length of stay if admitted

Posted

Median

Inter-Quartile Range

days

birth to neonatal hospital discharge (usually a maximum of 120 days)

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Number of Participants Experiencing Infant or Child Death

Death of infant or child before the 24 month study exam

Posted

Count of Participants

Participants

Birth to 24 month study exam

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Number of Children With Sensorineural Hearing Loss

Sensorineural hearing loss is defined as the occurrence or non-occurrence of sensorineural hearing loss defined as unilateral and bilateral sensorineural hearing loss

Hearing data was not available for approximately 25% of children due to loss to followup or consent refusal.

Posted

Count of Participants

Participants

12 and 24 months corrected age

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Number of Children Diagnosed With Chorioretinitis

Chorioretinitis is defined as the occurrence or non-occurrence of chorioretinitis defined by ophthalmologic exam

Posted

Count of Participants

Participants

2 years of age

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

Secondary

Mean Cognitive Composite Scores From the Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III)

The Bayley Scales of Infant and Toddler Development® | Third Edition (Bayley®-III), is a comprehensive tool to identify development issues during early childhood. The Bayley-III Cognitive Scale subtests assess cognitive function through the use of memory, problem solving and manipulation subtests. Scores on individual Cognitive subtests range from 1 (worst outcome) to 19 (better outcome) (Mean 10, SD 3). Individual subtest scores between 8 and 12 are considered average. The raw scores on the subtests are converted to scaled scores based on American norms by age. Cognitive Scale composite scores range from 55 (low, worse outcome) to 155 (high, better outcome) (mean 100; SD 15). Severe disability was defined as a composite score <70.

Posted

Mean

Standard Deviation

score on a scale

12 and 24 months corrected age

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Secondary

Mean Motor Composite Scores From the Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III)

The Bayley Scales of Infant and Toddler Development® | Third Edition (Bayley®-III), is a comprehensive tool to identify development issues during early childhood. The Bayley-III Motor Scale subtests assess motor function through fine motor and gross motor subtests. Scores on individual Motor subtests range from 1 (worst outcome) to 19 (better outcome) (Mean 10, SD 3). Individual subtest scores between 8 and 12 are considered average. The raw scores on the subtests are converted to scaled scores based on American norms by age. Motor Scale composite scores range from 55 (low, worse outcome) to 155 (high, better outcome) (mean 100; SD 15). Severe disability was defined as a composite score <70.

Posted

Mean

Standard Deviation

score on a scale

12 and 24 months corrected age

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Secondary

Number of Infants or Children With the Composite Outcome

Composite outcome at 24 months including any of the following attributable to congenital CMV infection: • Sensorineural hearing loss (unilateral and bilateral) • Developmental delay defined as Cognitive score < 70 or Motor score < 70 on the Bayley III • Chorioretinitis • Fetal loss or death of neonate, infant or child

Posted

Count of Participants

Participants

24 month study exam

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Overall Child Status at 24 Months of Age

Child status at age 24 months, classified as: • Fetal loss or death of neonate, infant or child • Congenital CMV infection with severe disability • Congenital CMV infection without severe disability • Infant not infected with CMV

Posted

Count of Participants

Participants

24 month study exam

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants

Secondary

Failure to Thrive at 24 Months

Failure to thrive defined as <10th percentile for weight at 24 months

Posted

Count of Participants

Participants

24 months of age

ID	Title	Description
OG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
OG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.

Units	Counts
Participants	OG000

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.	0	206	32	206	8	206
EG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.	0	193	25	193	7	193

Term	Organ System	Assessment Type	Statistical Information
hyperbilirubinemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected193 at risk
Supraventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected193 at risk
Congenital Anomaly	Congenital, familial and genetic disorders	Non-systematic Assessment	EG0009 events9 affected206 at risk EG0012 events2 affected193 at risk
Serious allergic reaction	General disorders	Non-systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected193 at risk
Meningitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected193 at risk
Renal mass	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected193 at risk
Corpus callosum lesion	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected193 at risk
Elective termination	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0005 events5 affected206 at risk EG0012 events2 affected193 at risk
Fetal death	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0004 events4 affected206 at risk EG0013 events3 affected193 at risk
Preterm birth	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG00012 events12 affected206 at risk EG00110 events10 affected193 at risk
Respiratory syncytial virus	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected193 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected193 at risk
Bronchiolitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected193 at risk
Meconium aspiration	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected193 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected193 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
congenital anomaly (non-serious)	Congenital, familial and genetic disorders		Non-systematic Assessment		EG0005 events5 affected206 at risk EG0015 events5 affected193 at risk
allergic reaction	Skin and subcutaneous tissue disorders		Non-systematic Assessment		EG0003 events3 affected206 at risk EG0012 events2 affected193 at risk

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Title	Description
BG000	CMV Hyperimmune Globulin - Cytogam®	Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
BG001	Placebo	IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W) Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
BG002	Total	Total of all reporting groups