Clinical trial NCT03731611: Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
Official title: Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placental Insufficiency
Preterm Infant
Keywords: Umbilical cord milking
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 90
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peripheral venous CD34 at admission
timeFrame: first 24 hours of infants' life
Secondary outcomes:
measure: Admission hemoglobin
timeFrame: first 24 hours of infants' life
measure: Hemoglobin at 2 months
timeFrame: 2 months after umbilical cord milking
measure: Admission platelets
timeFrame: first 24 hours of infants' life
measure: Admission WBCs
timeFrame: first 24 hours of infants' life
measure: Phototherapy requirements
timeFrame: first 28 days of life
measure: Polycythemia
timeFrame: first 28 days of life
measure: Culture proven sepsis
timeFrame: first 28 days of life
measure: Necrotizing enterocolitis
timeFrame: first 28 days of life
measure: Intraventricular hemorrhage
timeFrame: first 28 days of life
measure: Bronchopulmonary dysplasia
timeFrame: first 70 days of life
measure: Need for packed RBCs transfusion
timeFrame: first 28 days of life
measure: Retinopathy of prematurity
timeFrame: first 28 days of life
measure: Need for inotropes
timeFrame: first 28 days of life
measure: Need for nasal CPAP
timeFrame: first 28 days of life
measure: Need for mechanical ventilation
timeFrame: first 28 days of life
measure: Duration of oxygen therapy
timeFrame: first 70 days of life
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Children Hospital
state: El Dakahlya
city: Mansourah
country: Egypt
facility: Mansoura University Children's Hospital
Study officials:
References:
citation: 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.
citation: 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.