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A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.
This sub-study investigates the potential difference in neurodevelopmental outcomes during early childhood between newborns who undergo umbilical cord milking and those who experience early cord clamping at birth. The developmental progress of participants is evaluated using the Ages and Stages Questionnaire-3 which measures five developmental areas: communication, problem-solving, fine motor skills, gross motor skills, and personal-social behavior. Additionally, the Modified Checklist for Autism in Toddlers is employed as a secondary assessment. The recruitment of participants is conducted through the primary study Umbilical Cord Milking in Nonvigorous Infants trial (NCT03631940) with the method of umbilical cord management for each newborn being dictated by the randomized treatment allocation of the primary study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Milking | Active Comparator | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. |
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| Early Cord Clamping | Active Comparator | The umbilical cord is clamped as soon as possible and within 60 seconds of delivery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Milking | Procedure | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition. | Neurodevelopmental Outcome at 2 Years of Age defined as overall and domain scores on the Ages and Stages, third edition. Questionnaire. Minimum score of 0 and maximum score of 60 per domain. Scores from 5 subscales are summed to obtain a total score. 5 domains assessed include communication, gross motor, fine motor, problem solving, personal social with a total minimum score of 0 and maximum score of 300. Higher scores indicate a lower risk of developmental delays or conditions | 22 to 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire | Modified Checklist for Autism in Toddlers. Minimum score of 0 and maximum score of 20. Higher scores indicate higher risk for autism spectrum disorder. Total scores of 0 to 2 indicates a low risk of autism spectrum disorder. Total scores of 3 to 7 indicates a moderate risk of autism spectrum disorder. Total scores of 8 to 20 indicate high risk of autism spectrum disorder. |
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Inclusion Criteria:
Exclusion Criteria:
- Enrolled in the primary trial NCT:03631940 but parent/guardian declined consent to developmental follow-up participation.
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| Name | Affiliation | Role |
|---|---|---|
| Anup Katheria, MD | Neonatologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Davis | California | 95616 | United States | ||
| Loma Linda Medical Center |
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Hospital sites were informed of their randomization status two months before initiation of recruitment to permit time for physician and staff education on the assigned intervention. Prior to the start of recruitment in the crossover study period a 1 to 2-month washout period for each hospital site was specified by the protocol for the purpose of site hospital staff education on the change in assigned intervention and to assess adherence prior to recruitment initiation in the second study period.
Study design: cluster crossover randomization of 10 maternity hospitals to perform cord milking or early cord clamping. Participants were recruited among non-vigorous newborn born during the initial study period: January 2019 - January 2020 and crossover period: February 2020 - March 2021.
| ID | Title | Description |
|---|---|---|
| FG000 | Umbilical Cord Milking Then Early Cord Clamping Site Randomization - Infant | In the first study period infants assessed as non-vigorous at delivery had the umbilical cord is grasped by the obstetric provider, and blood was pushed toward the infant 4 times before the cord is clamped. In the second study period infants assessed as non-vigorous at delivery had the umbilical cord clamped by 60 seconds of life. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Randomized Intervention |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2022 |
Randomization assignment was determined at time of enrollment in the primary study (Umbilical Cord Milking in Nonvigorous Infants Study NCT:03631940). The primary study model was a cluster randomized crossover trial.
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Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
| Early Cord Clamping | Procedure | The umbilical cord is clamped as soon as possible and within 60 seconds of delivery. |
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| 22-26 months |
| Loma Linda |
| California |
| 92350 |
| United States |
| Sharp Grossmont Hospital | San Diego | California | 91942 | United States |
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225-6603 | United States |
| University of Utah/IMH | Salt Lake City | Utah | 84113 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2R3 | Canada |
| Dalhousie University | Dalhousie | New Brunswick | E8C 2R6 | Canada |
| Poznan University of Medical Science | Poznan | Poland |
| FG001 | Early Cord Clamping Then Umbilical Cord Milking Site Randomization - Infant | In the first study period infants assessed as non-vigorous at delivery had the umbilical cord clamped as soon as possible and within 60 seconds of delivery. In the second study period umbilical cord was grasped by the obstetric provider, and blood was pushed toward the infant 4 times before the cord is clamped. |
| COMPLETED |
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| NOT COMPLETED |
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| Crossover Randomized Intervention |
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Baseline characteristics are presented for all infant participants whose caregiver provided consent to participation in the 2-year follow-up study and whose caregiver completed an ASQ-3 Questionnaire when the child reached 2 years of age. All presented counts represent unique participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Umbilical Cord Milking Treatment Only- Infant & Maternal Baseline Measures | Baseline measures presented by randomized treatment assignment. Includes all infants who were assigned to umbilical cord milking (umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped) treatment based on hospital randomization. Maternal data is presented for all participating mothers. Only unique participants are presented. |
| BG001 | Early Cord Clamping Treatment Only- Infant & Maternal Baseline Measures | Baseline measures presented by randomized treatment assignment. Includes all infants who were assigned to the early cord clamping (The umbilical cord is clamped as soon as possible and within 60 seconds of delivery) treatment at delivery based on hospital randomization. Maternal data is presented for all participating mothers. Only unique participants are presented. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Infant's gestational age at delivery | Median | Inter-Quartile Range | weeks |
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| Age, Customized | Age of the mother at childbirth | Mean | Standard Deviation | years, maternal age at delivery |
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| Sex: Female, Male | Sex of infant participants. Maternal sex was not collected as a variable in the study dataset. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity of infant participants as reported by birth parents. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity of birth mother of participating infant as self-reported. | Count of Participants | Participants |
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| Race (NIH/OMB) | Infant race as reported by birth parents | Count of Participants | Participants |
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| Race (NIH/OMB) | Race of birth mother of participating infant as self-reported. | Count of Participants | Participants |
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| Region of Enrollment | Number | infant participants |
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| Number of neonates born to a mother with at least some college education | Baseline measure includes all infant-mother dyads who self-disclosed maternal highest level of education at the time of consent to long term follow-up participation. | Maternal level of education was not collected for infant-mother dyads who refused to self-disclose birth mother's highest level of education at time of consent to long-term follow-up. All participants represented are unique with no duplicate participants | Number | infant participants |
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| Count of newborns delivered by a mother with diabetes | Total number of infant participants whose mother had diabetes during gestation. | Number | number of infant participants |
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| Count of newborns delivered by a mother with hypertension | Total infant participants born to a mother with high blood pressure during gestation. | Number | number of infant participants |
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| Count of newborns delivered by a mother with intrauterine inflammation/infection | Total number of infants delivered by a mother with an intrauterine infection or inflammation condition during gestation. | Number | infant participants |
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| Count of newborns delivered by a mother with Group B Streptococcus | Total number of infants delivered by a mother with a positive Group B Streptococcus culture | One neonate-mother dyad in the umbilical cord clamping group has unknown screening status for Group B Streptococcus. | Number | infant participants |
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| Duration of fetal membrane rupture prior to delivery | Median | Inter-Quartile Range | hours since amnionic sac rupture |
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| Count of infants delivered by a mother administered narcotics/CNS depressants before delivery | Total count of infants delivered by a mother administered narcotics/central nervous system depressants within 2 hours of delivery. | Number | infant participants |
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| Count of infants delivered by cesarean section | Total number of infants born via surgical delivery (cesarean section) | Number | infant participants |
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| Count of infants born to a mother with a multiple birth pregnancy | Total number of infants that were part of a multiple gestation pregnancy. | Reported for all infant participants with maternal multiple gestation status collected. | Number | infant participants |
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| Count of newborns who were administered the correct randomized treatment at delivery | Total number of neonates who received the correct treatment assigned to the delivery hospital for all non-vigorous newborn delivered during the two enrollment periods. | Number | infant participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition. | Neurodevelopmental Outcome at 2 Years of Age defined as overall and domain scores on the Ages and Stages, third edition. Questionnaire. Minimum score of 0 and maximum score of 60 per domain. Scores from 5 subscales are summed to obtain a total score. 5 domains assessed include communication, gross motor, fine motor, problem solving, personal social with a total minimum score of 0 and maximum score of 300. Higher scores indicate a lower risk of developmental delays or conditions | Children who had Ages and Stages, third edition. Questionnaire scores available at 2 years or died before age 2 years. | Posted | Median | Inter-Quartile Range | score on a scale | 22 to 26 months |
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| Secondary | Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire | Modified Checklist for Autism in Toddlers. Minimum score of 0 and maximum score of 20. Higher scores indicate higher risk for autism spectrum disorder. Total scores of 0 to 2 indicates a low risk of autism spectrum disorder. Total scores of 3 to 7 indicates a moderate risk of autism spectrum disorder. Total scores of 8 to 20 indicate high risk of autism spectrum disorder. | Child participants with a total score from the Modified Checklist for Autism in Toddlers or died before the age of 2 years. | Posted | Count of Participants | Participants | 22-26 months |
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Infant's birth to 2 years of age.
Adverse events were assessed for infant participants only and were collected from delivery to 2 years of age.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Umbilical Cord Milking - Infant | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. | 2 | 502 | 0 | 502 | 0 | 502 |
| EG001 | Early Cord Clamping - Infant | The umbilical cord is clamped as soon as possible and within 60 seconds of delivery. | 5 | 469 | 0 | 469 | 0 | 469 |
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This study was conducted in relatively high-income academic centers. Most women had sufficient prenatal care, and almost 80% of the mothers had some college education.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anup Katheria | Sharp Healthcare | 8589394170 | Anup.Katheria@sharp.com |
| Sep 6, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Poland |
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| Fine motor score |
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| Problem solving score |
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| Personal-social score |
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| Total Ages and Stages Questionnaire score |
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