Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

Study Overview
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Brief Summary
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To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental insufficiency underwent DDC could have better hematologic parameters and hematopoietic progenitor cells compared to immediate cord clamping.

Detailed Description
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• A prospective randomized controlled study will be performed on preterm infants 34 weeks gestational age or less with placental insufficiency, and those without placental insufficiency where DCC will be performed in both groups. A third group of preterm with placental insufficiency and immediate cord clamping will be performed as a control.

Official Title
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Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

Conditions
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Preterm Infant, Placental Insufficiency, Placental Transfusion

Intervention / Treatment
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* Procedure: Delayed cord clamping


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
Maximum Age: 1 Minute

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>Placental insufficiency and ICC : Immediate cord clamping after delivery of the fetus in preterm infants with placental insufficiency | |
| Active Comparator: Group B<br>Placental insufficiency and DCC: Cord clamping 60 seconds after delivery of fetus in preterm infants with placental insufficiency | Procedure: Delayed cord clamping<br>* Cord clamping 60 seconds after delivery of fetus in preterm infants<br>|
| Active Comparator: Group C<br>Normal placenta with DCC:Cord clamping 60 seconds after delivery of fetus in preterm infants without placental insufficiency | Procedure: Delayed cord clamping<br>* Cord clamping 60 seconds after delivery of fetus in preterm infants<br>|

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 minutes 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 of infants' life | 
| 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 | first 24 hours of infants' life | 
| Phototherapy requirements |  | first 28 days of life | 
| Polycythemia |  | first 28 days of life | 
| Culture proven sepsis |  | first 28 days of life | 
| Necrotizing enterocolitis |  | first 28 days of life | 
| Intraventricular hemorrhage |  | first 28 days of life | 
| Bronchopulmonary dysplasia |  | first 70 days of life | 
| Need for nasal CPAP |  | first 28 days of life | 
| Need for mechanical ventilation |  | first 28 days of life | 
| Duration of oxygen therapy |  | first 28 days of life | 
| Need for inotropes |  | first 28 days of life | 
| Retinopathy of prematurity |  | first 28 days of life | 
| Need for packed RBCs transfusion |  | first 28 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delayed cord clamping, Preterm Infant, Placental Insufficiency, Intrauterine growth restriction