Safety of Furosemide in Premature Infants at Risk of Bron... | NCT02527798

ID	Type	Description	Link
HHSN27500033	Other Grant/Funding Number	National Institute of Child Health and Human Development (NICHD)
HHSN27500035	Other Grant/Funding Number	NICHD
5R01FD005101-02	U.S. FDA Grant/Contract		View source

Name	Class
Duke University	OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH
The Emmes Company, LLC	INDUSTRY

Label	Type	Description	Intervention Names
Furosemide Cohort 1	Experimental	Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days.	Drug: Furosemide Cohort 1
Placebo Cohort 1	Placebo Comparator	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).	Other: Placebo
Furosemide Cohort 2	Experimental	Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days.	Drug: Furosemide Cohort 2
Furosemide Cohort 3	Experimental	Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days.	Drug: Furosemide Cohort 3
Placebo Cohort 2	Placebo Comparator	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).

Name	Type	Description	Arm Group Labels	Other Names
Furosemide Cohort 1	Drug	furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.	Furosemide Cohort 1

Measure	Description	Time Frame
Safety as Determined by Adverse Events	Safety was assessed following the initial study-specific procedure (e.g., screening blood draws, dosing) through 7 days post last study dose by frequency and incidence of adverse events and serious adverse events.	35 days for each participant

Measure	Description	Time Frame
Moderate-Severe BPD or Death Risk Throughout Weekly Treatment	Moderate-severe BPD or death risk was defined by the NICHD Neonatal Research Network (NRN) BPD outcome estimator which provides an estimate of the risk of BPD (none, mild, moderate, severe) or death by postnatal day and is presented as a percentage. For this protocol, the categories were dichotomized to none-mild vs. moderate-severe-death. The risk of BPD or death was defined by the NICHD NRN BPD estimator on days 7, 14, 21 and 28 of study drug using the closest day available from the BPD estimator. The BPD estimator includes infants up to 28 postnatal days; for infants in this protocol older than that, 28-day estimates are used.

Name	Affiliation	Role
Matthew Laughon, MD, MPH	University of North Carolina, Chapel Hill	Principal Investigator
Jason E Lang, MD, MPH	Duke University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital/University of Arkansas for Medical Sciences		Little Rock	Arkansas	72202	United States

PubMed Identifier	Type	Citation	Retractions
40306549	Derived	Greenberg RG, Lang J, Smith PB, Shekhawat P, Courtney SE, Hudak ML, Moya F, Iyengar A, Eldemerdash A, Bloom B, Go M, Hanna M, Rhein L, Aliaga S, Lewis T, Febre A, Kiefer AS, Bhatt-Mehta V, Khoury JA, Selewski D, Anand R, Martz K, Payne EH, Zimmerman KO, Benjamin DK Jr, Laughon M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Furosemide Safety in Preterm Infants at Risk for Bronchopulmonary Dysplasia: A Randomized Clinical Trial. J Pediatr. 2025 Aug;283:114629. doi: 10.1016/j.jpeds.2025.114629. Epub 2025 Apr 28.

ID	Title	Description
FG000	Furosemide Cohort 1	Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days. Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 27, 2019	Aug 17, 2021

Arm/Group Information

ID	Title	Description
BG000	Furosemide Cohort 1	Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days. Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.
BG001	Placebo Cohort 1	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.
BG002	Furosemide Cohort 2	Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days. Furosemide Cohort 2: furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.
BG003	Placebo Cohort 2	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.
BG004	Furosemide Cohort 3	Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days. Furosemide Cohort 3: furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.
BG005	Placebo Cohort 3	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.
BG006	Total	Total of all reporting groups

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

Safety as Determined by Adverse Events

Safety was assessed following the initial study-specific procedure (e.g., screening blood draws, dosing) through 7 days post last study dose by frequency and incidence of adverse events and serious adverse events.

Based on Cohort 2 safety data analysis, enrollment was stopped prior to Cohort 3. Data are reported for the safety population.

Posted

Number

Events

35 days for each participant

ID	Title	Description
OG000	Furosemide Cohort 1	Within cohort 1, infants were randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive 1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days. Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.
OG001	Placebo Cohort 1	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.
OG002	Furosemide Cohort 2	Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days. Furosemide Cohort 2: furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.
OG003	Placebo Cohort 2	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.
OG004	Furosemide Cohort 3	Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days. Furosemide Cohort 3: furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.
OG005	Placebo Cohort 3	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.
OG006	Total	Sum of all groups

Units	Counts
Participants	OG00031 OG0019 OG00230 OG003

Title

Denominators

Categories

Title	Measurements
	OG000123 OG00129 OG002100 OG003

Secondary

Moderate-Severe BPD or Death Risk Throughout Weekly Treatment

Moderate-severe BPD or death risk was defined by the NICHD Neonatal Research Network (NRN) BPD outcome estimator which provides an estimate of the risk of BPD (none, mild, moderate, severe) or death by postnatal day and is presented as a percentage. For this protocol, the categories were dichotomized to none-mild vs. moderate-severe-death. The risk of BPD or death was defined by the NICHD NRN BPD estimator on days 7, 14, 21 and 28 of study drug using the closest day available from the BPD estimator. The BPD estimator includes infants up to 28 postnatal days; for infants in this protocol older than that, 28-day estimates are used.

Data are reported for the safety population. Overall 82 participants were randomized, but 2 were not dosed. 80 participants were analyzed for BPD status.

Based on Cohort 2 safety data analysis, enrollment was stopped prior to Cohort 3.

Posted

Mean

Standard Deviation

percent probability of BPD or death risk

Risk measured weekly through Week 4

ID	Title	Description
OG000	Furosemide Cohort 1	Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days. Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.
OG001	Placebo Cohort 1

Secondary

Number of Participants With Moderate-Severe BPD or Death Risk as Clinically Determined

Moderate-severe BPD or death risk was defined using the NICHD Neonatal Research Network BPD outcome estimator.

Data are reported for the safety population. Based on Cohort 2 safety data analysis, enrollment was stopped prior to Cohort 3.

Posted

Count of Participants

Participants

36 weeks postmenstrual age

ID	Title	Description
OG000	Furosemide Cohort 1	Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days. Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.
OG001	Furosemide Cohort 2	Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days. Furosemide Cohort 2: furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.
OG002	Placebo Cohort 1	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.

Secondary

Clearance

Data was collected from Furosemide/Active Cohort 1 and Cohort 2 and combined Cohorts. In total 39 active drug recipients participated. PK samples were collected after 7 days on study drug at recommended time points through 28 days on study drug plus one elimination (post drug discontinuation) time point.

Data was collected from the Furosemide cohort 1 and 2, and combined. In total 39 active drug recipients participated in the population PK.

Posted

Median

Full Range

(mL/h/kg)

After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.

ID	Title	Description
OG000	Furosemide Cohort 1	PK Population: Furosemide/Active drug arms from Cohort 1
OG001	Furosemide Cohort 2	PK Population: Furosemide/Active drug arms from Cohort 2
OG002	Furosemide (Cohort 1 and Cohort 2)	PK Population: Furosemide/Active drug arms from Cohort 1 and Cohort 2

Secondary

Volume of Distribution

Data was collected from the Furosemide Cohort 1 and Cohort 2 and combined. In total, 39 active drug recipients participated in the population PK.

Posted

Median

Full Range

ID	Title	Description
OG000	Furosemide Cohort 1	PK Population: Furosemide/Active drug arms from Cohort 1
OG001	Furosemide Cohort 2	PK Population: Furosemide/Active drug arms from Cohort 2
OG002	Furosemide All (Cohort 1 and Cohort 2)	PK Population: Furosemide/Active drug arms from Cohort 1 and Cohort 2

Secondary

Half-life

Data were collected from the two Furosemide cohorts and the combined analysis includes all 39 active drug recipients who participated in the population PK .

Posted

Median

Full Range

hours

ID	Title	Description
OG000	Furosemide Cohort 1	PK Population: Furosemide/Active drug from Cohort 1
OG001	Furosemide Cohort 2	PK Population: Furosemide/Active drug from Cohort 2
OG002	Furosemide Cohort 1 and Cohort 2	PK Population: Combined Furosemide/Active drug from Cohort 1 and Cohort 2

Secondary

Area Under the Plasma Concentration Versus Time Curve

Population PK data were collected from the two Furosemide cohorts and includes all 39 active drug recipients.

Posted

Median

Full Range

mg*h/L

ID	Title	Description
OG000	Furosemide Cohort 1	PK Population: Furosemide/Active drug from Cohort 1
OG001	Furosemide Cohort 2	PK Population: Furosemide/Active drug from Cohort 2
OG002	Furosemide (Cohort 1 and Cohort 2)	PK Population: Furosemide/Active drug from Cohort 1 and Cohort 2

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Furosemide Cohort 1	Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days. Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.	0	31	5	31	28	31
EG001	Placebo Cohort 1	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.	0	9	1	9	9	9
EG002	Furosemide Cohort 2	Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days. Furosemide Cohort 2: furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.	1	30	6	30	28	30
EG003	Placebo Cohort 2	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.	0	10	0	10	9	10
EG004	Furosemide Cohort 3	Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days. Furosemide Cohort 3: furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.	0	0	0	0	0	0
EG005	Placebo Cohort 3	Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug). Placebo: Sugar water will be administered in a equivalent volume as drug intervention.	0	0	0	0	0	0

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Patent ductus arteriosus	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG0030 events0 affected10 at risk EG0040 at risk EG0050 events0 affected0 at risk
Shock	Vascular disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Hydrocephalus	Nervous system disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Volvulus	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Meningitis herpes	Infections and infestations	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Intraventricular haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Necrotising colitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Seizure	Nervous system disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Necrotising colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Respiratory failure	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Renal Failure	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Respiratory track infection viral	Infections and infestations	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Petechiae	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG0031 events1 affected10 at risk EG0040 affected0 at risk EG0050 affected0 at risk
Chronic Respiratory Disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events5 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0005 events4 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Anaemia neonatal	Blood and lymphatic system disorders	Systematic Assessment	EG0004 events4 affected31 at risk EG0012 events2 affected9 at risk EG0020 events0 affected30 at risk EG003
Bandaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Cardiopulmonary failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected9 at risk EG0024 events3 affected30 at risk EG003
Patent ductus arteriosus	Congenital, familial and genetic disorders	Systematic Assessment	EG0003 events3 affected31 at risk EG0010 events0 affected9 at risk EG0025 events4 affected30 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Eyelid oedema	Eye disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Retinopathy of prematurity	Eye disorders	Systematic Assessment	EG0003 events3 affected31 at risk EG0011 events1 affected9 at risk EG0021 events1 affected30 at risk EG003
abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0004 events3 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Necrotising colitis	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Pneumonia escherichia	Infections and infestations	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Sepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected9 at risk EG0022 events2 affected30 at risk EG003
Tracheitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0021 events1 affected30 at risk EG003
Urinary tract infection bacterial	Infections and infestations	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0021 events1 affected30 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Blood alkaline phosphatase increased	Investigations	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Blood bicarbonate increased	Investigations	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0025 events4 affected30 at risk EG003
Blood creatinine increased	Investigations	Systematic Assessment	EG0002 events2 affected31 at risk EG0010 events0 affected9 at risk EG0025 events5 affected30 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Cholestasis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Bilirubin conjugate increased	Investigations	Systematic Assessment	EG0002 events2 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Blood sodium decreased	Investigations	Systematic Assessment	EG0005 events2 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Blood urea increased	Investigations	Systematic Assessment	EG0000 events0 affected31 at risk EG0018 events8 affected9 at risk EG0020 events0 affected30 at risk EG003
Cardiac murmur	Investigations	Systematic Assessment	EG0003 events3 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Chest X-ray abnormal	Investigations	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Gamma-glutamyltransferase increased	Investigations	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Platelet count decreased	Investigations	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Sputum culture positive	Investigations	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected31 at risk EG0012 events2 affected9 at risk EG0022 events2 affected30 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events4 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected31 at risk EG0010 events0 affected9 at risk EG0025 events4 affected30 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG00010 events10 affected31 at risk EG0011 events1 affected9 at risk EG0028 events7 affected30 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0012 events2 affected9 at risk EG0022 events2 affected30 at risk EG003
Growth retardation	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected9 at risk EG0021 events1 affected30 at risk EG003
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Hydrocephalus	Nervous system disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Hypertonia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Periventricular leukomalacia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Seizure	Nervous system disorders	Systematic Assessment	EG0003 events3 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Oliguria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Testicular swelling	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0020 events0 affected30 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected9 at risk EG0021 events1 affected30 at risk EG003
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0021 events1 affected30 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected9 at risk EG0022 events1 affected30 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected9 at risk EG0021 events1 affected30 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events2 affected31 at risk EG0011 events1 affected9 at risk EG0022 events2 affected30 at risk EG003
Embolism	Vascular disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected9 at risk EG0020 events0 affected30 at risk EG003

ID	Term
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
D013424	Sulfanilamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines
D013450	Sulfones
D013457	Sulfur Compounds