Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infant; Placental Insufficiency
• Intervention / Treatment: Procedure: Umbilical Cord Milking

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansourah, Egypt
    • Mansoura University Children's Hospital
  • El Dakahlya
    • Mansourah, El Dakahlya, Egypt, 35111
      • Mansoura University Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group A; umbilical cord milking will be done for preterm infants <34 gestational age without placental insufficiency	Procedure: Umbilical Cord Milking; 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.
ACTIVE_COMPARATOR: Group B; umbilical cord milking will be done for preterm infant <34 gestational age with placental insufficiency	Procedure: Umbilical Cord Milking; 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.
NO_INTERVENTION: Group C; Immediate cord clamping for preterm infants <34 gestational age with placental insufficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral venous CD34 at admission	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.	first 24 hours of infants' life

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University Children Hospital

Publications and helpful links

General Publications

• Li J, Yu B, Wang W, Luo D, Dai QL, Gan XQ. Does intact umbilical cord milking increase infection rates in preterm infants with premature prolonged rupture of membranes? J Matern Fetal Neonatal Med. 2020 Jan;33(2):184-190. doi: 10.1080/14767058.2018.1487947. Epub 2018 Sep 6.
• Kumar B, Upadhyay A, Gothwal S, Jaiswal V, Joshi P, Dubey K. Umbilical Cord Milking and Hematological Parameters in Moderate to Late Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2015 Sep;52(9):753-7. doi: 10.1007/s13312-015-0711-1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 3, 2018
• First Posted (ACTUAL): November 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Umbilical cord milking
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Obstetric Labor, Premature; Premature Birth; Placental Insufficiency
• Other Study ID Numbers: MS/17.07.44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No