Placental Transfusion Effect on Hemodynamics of Premature Newborns

NCT ID: NCT04811872

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-10-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intact umbilical cord milking (I-UCM)

Group Type: EXPERIMENTAL

Intact umbilical cord milking (I-UCM)

Intervention Type: BIOLOGICAL

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.

Cut-umbilical cord milking(C-UCM)

Group Type: EXPERIMENTAL

Cut-umbilical cord milking(C-UCM)

Intervention Type: BIOLOGICAL

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.

Delayed Cord Clamping (DCC )

Group Type: EXPERIMENTAL

Delayed Cord Clamping (DCC)

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Premature neonates ≤ 32 weeks gestational age regardless birth weight who will be admitted to neonatal intensive care unit in the first day of life.

Exclusion Criteria

• Preterm babies >32 weeks
• Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).
• Evidence of head trauma causing major intracranial hemorrhage.
• Monochorionic multiples.
• Concern for abruptions, placenta previa or retroplacental hematoma.
• Cord accident, or avulsion at the time of delivery.
• Refusal to perform the intervention by the obstetrician

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marwa Mohamed Farag

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mohamed Farag

Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, , Egypt

Countries

Egypt

References

Farag MM, Thabet MAEH, Abd-Almohsen AM, Ibrahim HIAM. The effect of placental transfusion on hemodynamics in premature newborns: a randomized controlled trial. Eur J Pediatr. 2022 Dec;181(12):4121-4133. doi: 10.1007/s00431-022-04619-0. Epub 2022 Sep 21.

Reference Type: DERIVED

PMID: 36129535 (View on PubMed)

Other Identifiers

0106459

Identifier Type: -

Identifier Source: org_study_id