Clinical trial NCT02827409: Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation.
Official title: A Randomized Controlled Trial of Short-Delay Cord Clamping as Compared to Extended- Delayed Cord Clamping in Term Neonates That Require Resuscitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placental Transfusion
Keywords: Delayed cord clamping
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Cerebral tissue oxygenation
timeFrame: 12 hours of life
Secondary outcomes:
measure: Heart rate
timeFrame: First 5 minutes of life
measure: Oxygen saturation
timeFrame: over the first 5 minutes of life
measure: delivery room resuscitation
timeFrame: at birth
measure: Blood pressure
timeFrame: 12 hours of life
measure: Hemoglobin
timeFrame: First 5 minutes of life
measure: Hemoglobin
timeFrame: 12 hours of life
measure: Apgar Score
timeFrame: First 10 minutes of life
measure: Arterial and Venous Umbilical Cord Blood Gases
timeFrame: At birth
measure: Need for NICU admission
timeFrame: at birth
measure: Need for hypothermia for hypoxic ischemic encepalopathy
timeFrame: at birth
measure: Hospitalization days
timeFrame: up to 24 weeks
measure: Bilirubin level
timeFrame: 12-48 hours
measure: Neurodevelopmental impairment
timeFrame: 12 month followup
measure: Post delivery survey
timeFrame: at birth
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp HealthCare
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.