Delayed Cord Clamping in Rhesus Disease of the Newborn

Benha University

Status: Unknown

Conditions: Rhesus Isoimmunization

Treatments: Procedure: Delayed cord clamping; Procedure: Early cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT04600674

RC 1-10-2020

Details and patient eligibility

About

The objective of this clinical trial is to investigate the effects of delayed cord clamping on hyperbilirubinemia, the need for phototherapy, neonatal intensive care (NICU) admission

Full description

The study will include term or preterm infants born to Rh negative mother.

The enrolled infants will be randomized into two groups:

Group (1) will include infants with delayed cord clamping performed at 60 sec after birth Group (2) will include infants with early cord clamping within 15 seconds.

History and examination The data on the gender, gestational age, birth weight, length, head circumference, 5- minute Apgar scores, presence of jaundice requiring phototherapy or exchange transfusion, need for admission in neonatal intensive care unit, the presence of respiratory distress (RR > 60 breath per minute) ,and length of hospitalization will be recorded.

The enrolled infants will be followed either with their mothers in the nursery or in NICU. Regarding the mothers; maternal age, maternal weight, any diseases, medication, and mode of delivery, and postpartum hemorrhage requiring blood transfusion will be recorded.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 1 minute old

Volunteers: No Healthy Volunteers

Inclusion criteria

• term or preterm infants born to Rh negative mother

Exclusion criteria

• Infants with Rh negative factor
• major congenital malformation
• fetal hydrops
• short umbilical cord less than 25cm
• nuchal cord
• multiple gestation
• unstable maternal hemodynamic condition
• placenta abruption
• placenta previa
• uterine rupture
• denied to participate
• depressed neonates who will require immediate resuscitation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

delayed cord clamping

Experimental group

Description:

DCC performed at 60 sec after birth

Treatment:

Procedure: Delayed cord clamping

early cord clamping

Experimental group

Description:

ECC performed at 15 sec after birth

Treatment:

Procedure: Early cord clamping