A Randomized Controlled Trial of Short-Delay Cord Clamping as Compared to Extended- Delayed Cord Clamping in Term Neonates That Require Resuscitation.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Placental Transfusion
- Sponsor
- Anup Katheria, M.D.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Cerebral tissue oxygenation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.
Detailed Description
All subjects will receive delayed cord clamping. One group (short-delay) will receive up to one minute of delayed cord clamping and then will be placed either on the mother's abdomen or the life-start trolley if extensive resuscitation is required. The second group will receive delayed cord clamping for at least 5 minutes and continue until the baby has established breathing without additional support or is stable on respiratory support (no longer received mask PPV for at least 1-2 minutes, i.e. stable on CPAP or intubated). The subject will initially be placed on the mother's abdomen or if the subject needs extensive resuscitation they will be moved to the LifeStart bed to receive resuscitation measures. In either group if the baby is deemed to be unstable (by medical team) to be on the life-start trolley the cord will be clamped and the baby will be moved to an adjacent warmer for resuscitation.
Investigators
Anup Katheria, M.D.
Director Neonatal Reseach Institute
Sharp HealthCare
Eligibility Criteria
Inclusion Criteria
- •Gestation 37 weeks or greater that require attendance at delivery of neonatal provider due to an at risk delivery.
Exclusion Criteria
- •Planned cesarean birth, placental abruption, multiple gestations, or known congenital anomalies.
Outcomes
Primary Outcomes
Cerebral tissue oxygenation
Time Frame: 12 hours of life
The need for oxygen, positive pressure ventilation, intubation
Secondary Outcomes
- Heart rate(First 5 minutes of life)
- Oxygen saturation(over the first 5 minutes of life)
- Arterial and Venous Umbilical Cord Blood Gases(At birth)
- Blood pressure(12 hours of life)
- delivery room resuscitation(at birth)
- Need for NICU admission(at birth)
- Hospitalization days(up to 24 weeks)
- Need for hypothermia for hypoxic ischemic encepalopathy(at birth)
- Hemoglobin(12 hours of life)
- Apgar Score(First 10 minutes of life)
- Neurodevelopmental impairment(12 month followup)
- Bilirubin level(12-48 hours)
- Post delivery survey(at birth)