NCT04811872

Placental Transfusion Effect on Hemodynamics of Premature Newborns

Evaluation of the Effect of Placental Transfusion on Hemodynamics in Premature Newborns

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Marwa Mohamed Farag · Academic / Other
• Sex: All
• Age: 0 Days – 1 Day
• Healthy volunteers: Not accepted

Summary

The objective of this study is to perform ultrasound Doppler measurements to evaluate the hemodynamic changes associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life.

Detailed description

This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.

Conditions

• Pre-Term

Interventions

Type	Name	Description
BIOLOGICAL	Intact umbilical cord milking (I-UCM)	Umblical cord milking will be performed by holding the newborn at or ∼20 cm below the level of the placenta. The cord will be pinched between 2 fingers as close to the placenta as possible and milked toward the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 1- to 2-second pause between each milking motion. This will be repeated for 2-4 times. After completion, the cord will be clamped, and the neonate will be handed to the resuscitation team.
BIOLOGICAL	Cut-umbilical cord milking(C-UCM)	This technique involves clamping and cutting a long segment of the umbilical cord immediately at birth and passing the baby and the long cord to the pediatric provider, called C-UCM untwists the cord and milks the entire contents into the baby. Milking the cord 2-3 times before clamping may produce a similar placental transfusion as C-UCM.
BIOLOGICAL	Delayed Cord Clamping (DCC)	Infants placed on the maternal abdomen or at the introitus below the level of placenta and waiting at least 30- to 60 seconds before clamping the cord.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-09-01
• Completion: 2021-10-01
• First posted: 2021-03-23
• Last updated: 2022-06-15

Locations

1 site across 1 country: Egypt