Placental Transfusion
Conditions
Keywords
Delayed cord clamping
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.
Interventions
PROCEDUREShort 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.
PROCEDUREExtended 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.
Sponsors
Anup Katheria, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
37 Weeks to 42 Weeks
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral tissue oxygenation | 12 hours of life | The need for oxygen, positive pressure ventilation, intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation | over the first 5 minutes of life | data will be averaged over each minute of life |
| delivery room resuscitation | at birth | did the infant require resuscitation such as stimulation to breathe, oxygen, positive pressure ventilation etc. |
| Blood pressure | 12 hours of life | — |
| Hemoglobin | First 5 minutes of life | if Hemoglobin oximeter available |
| Apgar Score | First 10 minutes of life | 1, 5 and 10 minute Apgar |
| Arterial and Venous Umbilical Cord Blood Gases | At birth | — |
| Heart rate | First 5 minutes of life | Heart rate obtained by pulse doppler, EKG, oximetry or a combination of all |
| Need for hypothermia for hypoxic ischemic encepalopathy | at birth | will be assessed by primary physician using defined criteria for hypothermia |
| Hospitalization days | up to 24 weeks | — |
| Bilirubin level | 12-48 hours | by transcutaneous or serum if available. percentile on curve will be document to adjust for different time frames. |
| Neurodevelopmental impairment | 12 month followup | by Ages and Stages questionnaire or Bayley 3scales of infant and toddler development |
| Post delivery survey | at birth | Survey of practitioners (LD nurse, OB, neonatal team) about procedure |
| Need for NICU admission | at birth | — |
Countries
United States
Outcome results
None listed