Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

NCT ID: NCT03731611

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-03-30

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.

Conditions

Placental Insufficiency; Preterm Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

umbilical cord milking will be done for preterm infants \<34 gestational age without placental insufficiency

Group Type: ACTIVE_COMPARATOR

Umbilical Cord Milking

Intervention Type: PROCEDURE

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.

Group B

umbilical cord milking will be done for preterm infant \<34 gestational age with placental insufficiency

Group Type: ACTIVE_COMPARATOR

Umbilical Cord Milking

Intervention Type: PROCEDURE

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.

Group C

Immediate cord clamping for preterm infants \<34 gestational age with placental insufficiency

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Minutes
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University Children Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nehad Nasef

Professor of pediatrics/Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, Egypt

Mansoura University Children's Hospital

Al Mansurah, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 29886779 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26519708 (View on PubMed)

Other Identifiers

MS/17.07.44

Identifier Type: -

Identifier Source: org_study_id