Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

Not Applicable

Completed

• Conditions: Placental Insufficiency; Preterm Infant
• Interventions: Procedure: Umbilical Cord Milking

• Registration Number: NCT03731611
• Lead Sponsor: Mansoura University Children Hospital

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 cm/sec. 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 Timeline

• Study First Submitted: 2018-11-03
• Study First Submitted QC: 2018-11-03
• Study First Posted: 2018-11-06
• Study Start: 2019-04-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• preterm neonates < 34 weeks gestational age

Exclusion Criteria

• Vaginal bleeding due to placental abruption or tears
• Multiple pregnancies
• Suspected major fetal anomalies
• Suspected chromosomal aberration
• Maternal drug abuse
• Hydrops fetalis
• preterm who needed major resuscitative measures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Umbilical Cord Milking	umbilical cord milking will be done for preterm infant \<34 gestational age with placental insufficiency
Group A	Umbilical Cord Milking	umbilical cord milking will be done for preterm infants \<34 gestational age without placental insufficiency

Primary Outcome Measures

Name	Time	Method
Peripheral venous CD34 at admission	first 24 hours of infants' life	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 Outcome Measures

Name	Time	Method
Hemoglobin at 2 months	2 months after umbilical cord milking	One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life.
Need for packed RBCs transfusion	first 28 days of life	number of packed RBCs transfusion
Retinopathy of prematurity	first 28 days of life	Prethreshold and threshold diseases Retinopathy of prematurity
Polycythemia	first 28 days of life	arterial Hematocrit value more than 70%
Necrotizing enterocolitis	first 28 days of life	Necrotizing enterocolitis (Any Bell's stage)
Duration of oxygen therapy	first 70 days of life	Duration of oxygen therapy
Admission WBCs	first 24 hours of infants' life	One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Phototherapy requirements	first 28 days of life	Need to start phototherapy for hyperbilirubinemia
Admission hemoglobin	first 24 hours of infants' life	One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Admission platelets	first 24 hours of infants' life	One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Need for nasal CPAP	first 28 days of life	respiratory distress requiring CPAP support
Need for mechanical ventilation	first 28 days of life	respiratory distress requiring mechanical ventilation support
Culture proven sepsis	first 28 days of life	Sepsis confirmed by positive blood culture
Intraventricular hemorrhage	first 28 days of life	Intraventricular hemorrhage of all grades
Bronchopulmonary dysplasia	first 70 days of life	Oxygen requirement at 36 weeks corrected gestational age
Need for inotropes	first 28 days of life	Hypotension requiring inotropic support

Trial Locations

Locations (2)

Mansoura University Children Hospital; 🇪🇬 Mansourah, El Dakahlya, Egypt

Mansoura University Children's Hospital; 🇪🇬 Mansourah, Egypt