Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

Mansoura University Children Hospital

Status: Completed

Conditions: Preterm Infant; Placental Insufficiency

Treatments: Procedure: Umbilical Cord Milking

Study type: Interventional

Funder types: Other

Identifiers

NCT03731611

MS/17.07.44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Procedure: Umbilical Cord Milking

Group B

Active Comparator group

Description:

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

Treatment:

Procedure: Umbilical Cord Milking

Group C

No Intervention group

Description:

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