Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infant; Placental Transfusion; Placental Insufficiency
• Intervention / Treatment: Procedure: Delayed 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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansourah, Egypt
    • Mansoura University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 minute (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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
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
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 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

Collaborators and Investigators

• Sponsor: Mansoura University Children Hospital

Publications and helpful links

General Publications

• Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
• Gokmen Z, Ozkiraz S, Tarcan A, Kozanoglu I, Ozcimen EE, Ozbek N. Effects of delayed umbilical cord clamping on peripheral blood hematopoietic stem cells in premature neonates. J Perinat Med. 2011 May;39(3):323-9. doi: 10.1515/jpm.2011.021. Epub 2011 Mar 11.
• Yunis M, Nour I, Gibreel A, Darwish M, Sarhan M, Shouman B, Nasef N. Effect of delayed cord clamping on stem cell transfusion and hematological parameters in preterm infants with placental insufficiency: a pilot randomized trial. Eur J Pediatr. 2021 Jan;180(1):157-166. doi: 10.1007/s00431-020-03730-4. Epub 2020 Jul 4. Erratum In: Eur J Pediatr. 2022 Sep;181(9):3561-3562.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 3, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Delayed cord clamping; Preterm Infant; Intrauterine growth restriction; Placental Insufficiency
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Obstetric Labor, Premature; Premature Birth; Placental Insufficiency
• Other Study ID Numbers: MS/17.04.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No