Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

Preterm Infant Clinical Trial

Official title:

Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731611
• Other study ID #: MS/17.07.44
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2022
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 30, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Placental Insufficiency
• Premature Birth
• Preterm Infant

Intervention

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.

Locations

Country	Name	City	State
Egypt	Mansoura University Children Hospital	Mansourah	El Dakahlya
Egypt	Mansoura University Children's Hospital	Mansourah

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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: 10.1080/14767058.2018.148794 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Phototherapy requirements	Need to start phototherapy for hyperbilirubinemia	first 28 days of life
Secondary	Polycythemia	arterial Hematocrit value more than 70%	first 28 days of life
Secondary	Culture proven sepsis	Sepsis confirmed by positive blood culture	first 28 days of life
Secondary	Necrotizing enterocolitis	Necrotizing enterocolitis (Any Bell's stage)	first 28 days of life
Secondary	Intraventricular hemorrhage	Intraventricular hemorrhage of all grades	first 28 days of life
Secondary	Bronchopulmonary dysplasia	Oxygen requirement at 36 weeks corrected gestational age	first 70 days of life
Secondary	Need for packed RBCs transfusion	number of packed RBCs transfusion	first 28 days of life
Secondary	Retinopathy of prematurity	Prethreshold and threshold diseases Retinopathy of prematurity	first 28 days of life
Secondary	Need for inotropes	Hypotension requiring inotropic support	first 28 days of life
Secondary	Need for nasal CPAP	respiratory distress requiring CPAP support	first 28 days of life
Secondary	Need for mechanical ventilation	respiratory distress requiring mechanical ventilation support	first 28 days of life
Secondary	Duration of oxygen therapy	Duration of oxygen therapy	first 70 days of life