VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants

Study Overview
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Brief Summary
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The purpose of this study is to determine whether providing ventilatory assistance prior to umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in extremely preterm (EPT) infants, compared to standard care of providing ventilatory assistance after cord clamping.

Detailed Description
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Newborns with gestational age 23 wks 0 days through 28 wks 6 days are randomized to control (delayed cord clamping for at least 30 seconds, or up to 60 seconds if breathing spontaneously, with ventilatory assistance provided after) or the VentFirst intervention (ventilatory assistance with continuous positive airway pressure or positive pressure ventilation given starting 30 seconds after birth and cord clamping at 120 seconds). The primary outcome is lack of IVH on 7-10 day head ultrasound or death before day 7. The study was designed to test the impact of the intervention in each of two cohorts: Infants not breathing well 30 seconds after birth Infants breathing well 30 seconds after birth Randomization and analysis is stratified by gestational age category: 23 0/6 to 25 6/7 weeks' gestation 26 0/7 to 28 6/7 weeks' gestation

Official Title
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VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants

Conditions
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Intraventricular Hemorrhage

Intervention / Treatment
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* Procedure: Standard 30-60 Seconds Cord Clamping
* Procedure: VentFirst 120 Seconds Cord Clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 23 0/7 - 28 6/7 weeks' gestation at delivery Exclusion Criteria: Life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal abnormality, severe congenital malformation) Suspected severe fetal anemia Monochorionic or monoamniotic twins Multiple gestation greater than twins Decision made for comfort care only Medical emergency necessitating emergency delivery (e.g. complete placental abruption) Obstetrician or Neonatology concern for inappropriateness of the study intervention based on maternal or fetal factors.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard 30-60 Seconds Cord Clamping<br>Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after cord clamping. | Procedure: Standard 30-60 Seconds Cord Clamping<br>* The infant is stimulated to breathe after birth. If the infant is not breathing well, the cord is clamped at 30 seconds. If the baby is breathing well, the cord is clamped at 60 seconds. Ventilatory assistance is given after cord clamping.<br>|
| Experimental: VentFirst 120 Seconds Cord Clamping<br>Assisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds. | Procedure: VentFirst 120 Seconds Cord Clamping<br>* The infant is stimulated to breathe after birth. If the infant is not breathing well, PPV by face mask is given starting at 30 seconds. If the baby is breathing well, CPAP is given starting at 30 seconds. The cord is clamped at 120 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age | presence of any grade IVH on HUS | 7-10 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 minute Apgar Score <5 | Low Apgar score (<5) at 5 minutes | 5 minutes after birth | 
| Lowest hematocrit in first 24 hours | Median, 25th & 75th percentiles | First 24 hours after birth | 
| Medication for low blood pressure in first 24 hours | Hydrocortisone and/or vasopressor for hypotension | First 24 hours after birth | 
| Number of red blood cell transfusions birth through day 10 | Median, 25th & 75th percentiles | First 10 days after birth | 
| Severe brain injury on head ultrasound | Grade 3-4 IVH and/or cerebellar hemorrhage and/or cystic periventricular leukomalacia on head ultrasound at 7-10 days of age and/or near 36 weeks' postmenstrual age | Birth through 36 weeks' postmenstrual age | 
| Death | All-cause mortality | Birth through 36 weeks' postmenstrual age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical Cord Clamping, Intraventricular Hemorrhage, Extremely Preterm Infants