Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

Conditions
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Placental Insufficiency, Preterm Infant

Intervention / Treatment
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* Procedure: Umbilical Cord Milking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>umbilical cord milking will be done for preterm infants <34 gestational age without placental insufficiency | Procedure: Umbilical Cord Milking<br>* 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.<br>|
| Active Comparator: Group B<br>umbilical cord milking will be done for preterm infant <34 gestational age with placental insufficiency | Procedure: Umbilical Cord Milking<br>* 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.<br>|
| No Intervention: Group C<br>Immediate cord clamping for preterm infants <34 gestational age with placental insufficiency | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical cord milking