Clinical trial NCT04600674: Delayed Cord Clamping in Rhesus Disease of the Newborn
Official title: Delayed Cord Clamping in Rhesus Disease of the Newborn: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhesus Isoimmunization
Keywords: Rhesus Disease
Newborn
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 30
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hematocrit value
timeFrame: 2 hours
Secondary outcomes:
measure: Bilirubin level
timeFrame: 24 hours
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospital
state: Qalubia
Study officials:
affiliation: Sohag Faculty of Medicine, Sohag University
name: Ramadan A Mahmoud, MD
role: STUDY_CHAIR
affiliation: Benha Faculty of Medicine, Benha University
name: Rana A Khashaba, MD
role: STUDY_CHAIR
affiliation: Benha Faculty of Medicine, Benha University
name: Walid M Tawfik, MD
role: STUDY_CHAIR
References:
citation: Garabedian C, Rakza T, Drumez E, Poleszczuk M, Ghesquiere L, Wibaut B, Depoortere MH, Vaast P, Storme L, Houfflin-Debarge V. Benefits of Delayed Cord Clamping in Red Blood Cell Alloimmunization. Pediatrics. 2016 Mar;137(3):e20153236. doi: 10.1542/peds.2015-3236. Epub 2016 Feb 18.
citation: Vural I, Ozdemir H, Teker G, Yoldemir T, Bilgen H, Ozek E. Delayed cord clamping in term large-for-gestational age infants: A prospective randomised study. J Paediatr Child Health. 2019 May;55(5):555-560. doi: 10.1111/jpc.14242. Epub 2018 Oct 4.