Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600674
Status:
UNKNOWN
Last Update Posted:
2022-03-07
First Post:
2020-10-19
Brief Title:
Delayed Cord Clamping in Rhesus Disease of the Newborn
Sponsor:
Benha University
Organization:
Benha University
Study Overview
Official Title:
Delayed Cord Clamping in Rhesus Disease of the Newborn A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None