Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
Primary Purpose
Placental Insufficiency, Preterm Infant
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Umbilical Cord Milking
Sponsored by
About this trial
This is an interventional treatment trial for Placental Insufficiency focused on measuring Umbilical cord milking
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
Sites / Locations
- Mansoura University Children Hospital
- Mansoura University Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Group A
Group B
Group C
Arm Description
umbilical cord milking will be done for preterm infants <34 gestational age without placental insufficiency
umbilical cord milking will be done for preterm infant <34 gestational age with placental insufficiency
Immediate cord clamping for preterm infants <34 gestational age with placental insufficiency
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Admission hemoglobin
One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Hemoglobin at 2 months
One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life.
Admission platelets
One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Admission WBCs
One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Phototherapy requirements
Need to start phototherapy for hyperbilirubinemia
Polycythemia
arterial Hematocrit value more than 70%
Culture proven sepsis
Sepsis confirmed by positive blood culture
Necrotizing enterocolitis
Necrotizing enterocolitis (Any Bell's stage)
Intraventricular hemorrhage
Intraventricular hemorrhage of all grades
Bronchopulmonary dysplasia
Oxygen requirement at 36 weeks corrected gestational age
Need for packed RBCs transfusion
number of packed RBCs transfusion
Retinopathy of prematurity
Prethreshold and threshold diseases Retinopathy of prematurity
Need for inotropes
Hypotension requiring inotropic support
Need for nasal CPAP
respiratory distress requiring CPAP support
Need for mechanical ventilation
respiratory distress requiring mechanical ventilation support
Duration of oxygen therapy
Duration of oxygen therapy
Full Information
NCT ID
NCT03731611
First Posted
November 3, 2018
Last Updated
May 2, 2022
Sponsor
Mansoura University Children Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03731611
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Children Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placental Insufficiency, Preterm Infant
Keywords
Umbilical cord milking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
umbilical cord milking will be done for preterm infants <34 gestational age without placental insufficiency
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
umbilical cord milking will be done for preterm infant <34 gestational age with placental insufficiency
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Immediate cord clamping for preterm infants <34 gestational age with placental insufficiency
Intervention Type
Procedure
Intervention Name(s)
Umbilical Cord Milking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peripheral venous CD34 at admission
Description
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.
Time Frame
first 24 hours of infants' life
Secondary Outcome Measure Information:
Title
Admission hemoglobin
Description
One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Time Frame
first 24 hours of infants' life
Title
Hemoglobin at 2 months
Description
One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life.
Time Frame
2 months after umbilical cord milking
Title
Admission platelets
Description
One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Time Frame
first 24 hours of infants' life
Title
Admission WBCs
Description
One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Time Frame
first 24 hours of infants' life
Title
Phototherapy requirements
Description
Need to start phototherapy for hyperbilirubinemia
Time Frame
first 28 days of life
Title
Polycythemia
Description
arterial Hematocrit value more than 70%
Time Frame
first 28 days of life
Title
Culture proven sepsis
Description
Sepsis confirmed by positive blood culture
Time Frame
first 28 days of life
Title
Necrotizing enterocolitis
Description
Necrotizing enterocolitis (Any Bell's stage)
Time Frame
first 28 days of life
Title
Intraventricular hemorrhage
Description
Intraventricular hemorrhage of all grades
Time Frame
first 28 days of life
Title
Bronchopulmonary dysplasia
Description
Oxygen requirement at 36 weeks corrected gestational age
Time Frame
first 70 days of life
Title
Need for packed RBCs transfusion
Description
number of packed RBCs transfusion
Time Frame
first 28 days of life
Title
Retinopathy of prematurity
Description
Prethreshold and threshold diseases Retinopathy of prematurity
Time Frame
first 28 days of life
Title
Need for inotropes
Description
Hypotension requiring inotropic support
Time Frame
first 28 days of life
Title
Need for nasal CPAP
Description
respiratory distress requiring CPAP support
Time Frame
first 28 days of life
Title
Need for mechanical ventilation
Description
respiratory distress requiring mechanical ventilation support
Time Frame
first 28 days of life
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy
Time Frame
first 70 days of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Minutes
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mansoura University Children Hospital
City
Mansourah
State/Province
El Dakahlya
ZIP/Postal Code
35111
Country
Egypt
Facility Name
Mansoura University Children's Hospital
City
Mansourah
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29886779
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.
Results Reference
result
PubMed Identifier
26519708
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.
Results Reference
result
Learn more about this trial
Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
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