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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP or PPV during DCC | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP or PPV during DCC | Procedure | CPAP or PPV is provided during delayed cord clamping |
|
| 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 |
| 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 |
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Inclusion Criteria:
- 24 0/7 to 32 6/7 weeks gestation at birth
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen D Fairchild, MD | University of Virginia SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia School of Medicine | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27305177 | Result | Winter J, Kattwinkel J, Chisholm C, Blackman A, Wilson S, Fairchild K. Ventilation of Preterm Infants during Delayed Cord Clamping (VentFirst): A Pilot Study of Feasibility and Safety. Am J Perinatol. 2017 Jan;34(2):111-116. doi: 10.1055/s-0036-1584521. Epub 2016 Jun 15. |
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| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |