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Placental Transfusion Effect on Hemodynamics of Premature Newborns

M

Marwa Mohamed Farag

Status and phase

Completed
Phase 3
Phase 2

Conditions

Pre-Term

Treatments

Biological: Cut-umbilical cord milking(C-UCM)
Biological: Intact umbilical cord milking (I-UCM)
Biological: Delayed Cord Clamping (DCC)

Study type

Interventional

Funder types

Other

Identifiers

NCT04811872
0106459

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

All

Ages

Under 1 day old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

57 participants in 3 patient groups

Intact umbilical cord milking (I-UCM)
Experimental group
Treatment:
Biological: Intact umbilical cord milking (I-UCM)
Cut-umbilical cord milking(C-UCM)
Experimental group
Treatment:
Biological: Cut-umbilical cord milking(C-UCM)
Delayed Cord Clamping (DCC )
Experimental group
Treatment:
Biological: Delayed Cord Clamping (DCC)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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