Ignite Creation Date:
2024-05-06 @ 12:19 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03731611
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2018-11-03
Brief Title:
Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
Sponsor:
Mansoura University Children Hospital
Organization:
Mansoura University Children Hospital
Study Overview
Official Title:
Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
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:
To investigate the effect of umbilical cord milking UCM on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants 34 weeks gestational age with placental insufficiency We hypothesize that UCM would enhance peripheral CD34 concentration hemoglobin and reduce prematurity complications like NEC and IVH in preterm infant 34 week gestational age with placental insufficiency
Detailed Description:
A pilot prospective randomized controlled study will be conducted among 3 groups all of them are preterm less than 34 weeks gestational age in the first group umbilical cord milking will be done for preterm infant with placental insufficiency Two control groups are present in the first one umbilical cord milking will be done for preterm infants without placental insufficiency Insufficiency vs no insufficiency another group of immediate cord clamping for preterm infants with placental insufficiency will be added milking vs no milking 30 cases will be recruited in each group
Umbilical cord milking UCM is typically performed by placing the infant below the level of the placenta The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cmsec After completion the cord is clamped and the neonate is handed to the resuscitation team
One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry Secondary outcomes will be documented during NICU stay that include admission CBC peak bilirubin concentrations CBC after 2 months neonatal morbidity such as sepsis bronchopulmonary dysplasia necrotizing enterocolitis retinopathy of prematurity and polycythemia therapeutic interventions such as need for inotropes nasal CPAP mechanical ventilation and phototherapy
Umbilical cord milking UCM is typically performed by placing the infant below the level of the placenta The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cmsec After completion the cord is clamped and the neonate is handed to the resuscitation team
One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry Secondary outcomes will be documented during NICU stay that include admission CBC peak bilirubin concentrations CBC after 2 months neonatal morbidity such as sepsis bronchopulmonary dysplasia necrotizing enterocolitis retinopathy of prematurity and polycythemia therapeutic interventions such as need for inotropes nasal CPAP mechanical ventilation and phototherapy
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