Delayed Cord Clamping in Rhesus Disease of the Newborn

Rhesus Isoimmunization Clinical Trial

Official title:

Delayed Cord Clamping in Rhesus Disease of the Newborn: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600674
• Other study ID #: RC 1-10-2020
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2022
• Source: Benha University
• Contact: Shaimaa R Abdelmaksoud, MD
• Phone: 01001814411
• Email: shaimaareda82[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Minute

Eligibility

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

Related Conditions & MeSH terms

• Rhesus Isoimmunization

Intervention

Procedure:
• Delayed cord clamping
DCC performed at 60 sec after birth
• Early cord clamping
ECC performed at 15 sec after birth

Locations

Country	Name	City	State
Egypt	Benha University Hospital	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematocrit value	Hematocrit will be measured at 2 hours of life (percent %)	2 hours
Secondary	Bilirubin level	Bilirubin level will be measured at 24 hours of life (mg/dl)	24 hours