Preterm Infant
Conditions
Keywords
preterm infant, delayed cord clamping, cord milking, resuscitation
Brief summary
In this feasibility study, the investigators will randomize preterm infants born at \<32 weeks gestation to either the standard practice of delayed cord clamping (DCC) for 30-60 seconds at birth or milking of the long-cut cord (MOCC) while providing resuscitation/stabilization to the infant. The main objectives of the trial are to assess the feasibility of the new approach (MOCC) and to compare the two groups regarding the hemoglobin levels on admission to NICU in addition to neonatal morbidity and mortality.
Interventions
PROCEDUREMOCC Group
After 30 seconds of DCC, the cord will be clamped and cut 5 cm from the introitus in vaginal delivery or abdominal incision in the case of cesarean section before passing the infant with the long umbilical cord segment to the pediatric provider who will milk the cord one time towards the baby during resuscitation.
PROCEDUREDCC Group
The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds. After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.
Sponsors
IWK Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Minutes
Healthy volunteers
No
Inclusion criteria
* Preterm infants \<32 weeks' gestation
Exclusion criteria
* Clinical evidence of interrupted placental circulation (placental abruption or avulsed cord) or bleeding from placenta previa. * Monochorionic twins or any higher order multiple pregnancy * Major fetal congenital or chromosomal abnormality * Documented fetal anemia or in utero red blood cell transfusion * Intent to withhold or withdraw treatment of the infant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events associated with the MOCC intervention | Till the participants reach 2 year- corrected age (around 4.5 years) | To investigate any adverse events that could be attributed to the MOCC intervention. |
| Rate of compliance to the study intervention | Two years | to investigate the adherence to the new approach of MOCC during resuscitation/ stabilization following 30 seconds of DCC in preterm infants. |
| Number of patients completing the study | Two years | To evaluate the number of patients who are recruited and completed the study to estimate the sample size needed for the design of a large multi-centre RCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare hemoglobin (Hgb) concentration | From date of randomization and assessed up to 24 hours of age | to compare hemoglobin (Hgb) concentration on NICU admission in preterm infants \<32 weeks' gestation who receive MOCC during resuscitation/stabilization following 30 seconds of DCC with those who receive DCC alone for 30-60 seconds at birth (standard practice-control group). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cerebral oxygenation | From randomization assessed up to 72 hours of age | Measure the cerebral oxygenation using NIRS |
| Blood transfusion | From randomization assessed up to 36 weeks corrected gestational age | Assess the number of blood transfusions baby received from birth |
| Temperature stability | From randomization assessed up to 2 hours of age | Temperature on admission to NICU |
| Long-term outcomes | 24 Months Corrected age | Long-term neurodevelopmental outcomes at 18-24 months of corrected age. |
| Intraventricular hemorrhage (IVH) | From randomization assessed up to 36 weeks corrected age | Assess the grade of IVH |
| Need for advanced resuscitation at birth | From randomization assessed up to 2 hours of age | Need for advanced resuscitation including intubation, chest compressions and/or medications |
| Inotropic support | From randomization assessed up to 72 hours of age | Need for inotropic medication support |
| Volume expander | From randomization assessed up to 72 hours of age | Assess the need for a volume expander (saline bolus or albumin bolus) |
Countries
Canada
Contacts
Primary ContactWalid El-Naggar, MD
Backup ContactJon Dorling, MD
Outcome results
None listed