Infant, Premature, Diseases
Conditions
Keywords
preterm infant
Brief summary
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
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.
Interventions
PROCEDURECPAP or PPV during DCC
CPAP or PPV is provided during delayed cord clamping
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of deliveries in which providing ventilatory assistance during delayed cord clamping is achieved | 90 seconds after birth | Assess the feasibility of the neonatology team performing initial resuscitation and providing ventilation during 90 seconds of delayed cord clamping |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of unanticipated complications of neonatal resuscitation during delayed cord clamping (neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables) | 7 days from birth | Assess neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables |
Countries
United States
Outcome results
None listed