Trials / Completed
CompletedNCT02827409
Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation.
A Randomized Controlled Trial of Short-Delay Cord Clamping as Compared to Extended- Delayed Cord Clamping in Term Neonates That Require Resuscitation.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Anup Katheria, M.D. · Academic / Other
- Sex
- All
- Age
- 37 Weeks – 42 Weeks
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Short Delay Cord Clamping | Delay cord clamping will occur for up to 1 minute. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the radiant warmer for resuscitation. |
| PROCEDURE | Extended Delay Cord Clamping | Extended delay cord clamping will occur for at least 5 minutes and will continue until the subjects begins breathing and/or the cord stops pulsating. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the LifeStart bed for resuscitation adjacent to the mother's bedside. |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2016-09-01
- Completion
- 2016-12-01
- First posted
- 2016-07-11
- Last updated
- 2017-06-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02827409. Inclusion in this directory is not an endorsement.