Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation. (Term-NRIC)

Anup Katheria, M.D.

Status: Completed

Conditions: Placental Transfusion

Treatments: Procedure: Short Delay Cord Clamping; Procedure: Extended Delay Cord Clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT02827409

Term-NRIC

Details and patient eligibility

About

To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 37 to 42 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Short Delay Cord Clamping

Active Comparator group

Description:

Subject will have umbilical cord clamped and cut by 1 minute of life.

Treatment:

Procedure: Short Delay Cord Clamping

Extended Delay Cord Clamping

Active Comparator group

Description:

Subject will have umbilical cord clamped and cut after at least 5 minutes of delayed cord clamping. Duration of cord clamping after 5 minutes will depend on if the subject is breathing and/or if the cord has stopped pulsating

Treatment:

Procedure: Extended Delay Cord Clamping