Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

Not Applicable

Completed

• Conditions: Preterm Infant; Placental Insufficiency; Placental Transfusion
• Interventions: Procedure: Delayed cord clamping

• Registration Number: NCT03731546
• Lead Sponsor: Mansoura University Children Hospital

Brief Summary

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

• 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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-11-03
• Study First Submitted QC: 2018-11-03
• Study First Posted: 2018-11-06
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-15
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Delayed cord clamping	Placental insufficiency and DCC: Cord clamping 60 seconds after delivery of fetus in preterm infants with placental insufficiency
Group C	Delayed cord clamping	Normal placenta with DCC:Cord clamping 60 seconds after delivery of fetus in preterm infants without placental insufficiency

Primary Outcome Measures

Name	Time	Method
Peripheral venous CD34 at admission	first 24 hours of infants' life	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.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin at 2 months	2 months of infants' life	One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life.
Intraventricular hemorrhage	first 28 days of life
Retinopathy of prematurity	first 28 days of life
Admission hemoglobin	first 24 hours of infants' life	One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Polycythemia	first 28 days of life
Necrotizing enterocolitis	first 28 days of life
Duration of oxygen therapy	first 28 days of life
Bronchopulmonary dysplasia	first 70 days of life
Need for nasal CPAP	first 28 days of life
Admission platelets	first 24 hours of infants' life	One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Culture proven sepsis	first 28 days of life
Need for mechanical ventilation	first 28 days of life
Need for inotropes	first 28 days of life
Need for packed RBCs transfusion	first 28 days of life
Admission WBCs	first 24 hours of infants' life	One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24
Phototherapy requirements	first 28 days of life

Trial Locations

Locations (1)

Mansoura University Children's Hospital; 🇪🇬 Mansourah, Egypt