VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

Study Overview
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Brief Summary
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Delayed clamping of the umbilical cord (DCC) has been shown to have some benefits for preterm infants. Initiation of breathing before cord clamping is also thought to be beneficial. Since some preterm infants do not breathe well on their own immediately after birth, assisting ventilation during delayed cord clamping might have additional benefit beyond DCC alone. VentFirst Pilot will assess feasibility and safety of assisting ventilation of preterm infants during 90 seconds of DCC which is essential before proceeding to a randomized clinical trial.

Detailed Description
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Mothers expected to deliver an infant at 24-32 completed weeks' gestation will be approached for consent. When the infant is delivered, members of the neonatology team will be at the mother's side and will provide initial steps of resuscitation (position, suction, stimulate) per guidelines of the Neonatology Resuscitation Program (NRP). At 30 seconds after birth, the infant will receive continuous positive airway pressure (CPAP) if breathing well, or positive pressure ventilation (PPV) if not breathing well. At 90 seconds, the umbilical cord will be cut and the remainder of the resuscitation and stabilization will be carried out in the usual location.

Official Title
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VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

Conditions
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Infant, Premature, Diseases

Intervention / Treatment
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* Procedure: CPAP or PPV during DCC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 24 0/7 to 32 6/7 weeks gestation at birth Exclusion Criteria: major congenital anomalies monochorionic twins twin-twin transfusion syndrome hydrops fetalis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP or PPV during DCC<br>Infant will receive CPAP or PPV from 30 to 90 seconds after birth while attached to the placenta, and then the umbilical cord will be cut at 90 seconds | Procedure: CPAP or PPV during DCC<br>* CPAP or PPV is provided during delayed cord clamping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of deliveries in which providing ventilatory assistance during delayed cord clamping is achieved | Assess the feasibility of the neonatology team performing initial resuscitation and providing ventilation during 90 seconds of delayed cord clamping | 90 seconds after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unanticipated complications of neonatal resuscitation during delayed cord clamping (neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables) | Assess neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables | 7 days from birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infant