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Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

Primary Purpose

Preterm Infant, Placental Insufficiency, Placental Transfusion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Delayed cord clamping
Sponsored by
Mansoura University Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infant focused on measuring Delayed cord clamping, Preterm Infant, Placental Insufficiency, Intrauterine growth restriction

Eligibility Criteria

0 Minutes - 1 Minute (Child)All SexesDoes not accept healthy volunteers

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's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Placental insufficiency and ICC : Immediate cord clamping after delivery of the fetus in preterm infants with placental insufficiency

Placental insufficiency and DCC: Cord clamping 60 seconds after delivery of fetus in preterm infants with placental insufficiency

Normal placenta with DCC:Cord clamping 60 seconds after delivery of fetus in preterm infants without 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 minutes 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
Phototherapy requirements
Polycythemia
Culture proven sepsis
Necrotizing enterocolitis
Intraventricular hemorrhage
Bronchopulmonary dysplasia
Need for nasal CPAP
Need for mechanical ventilation
Duration of oxygen therapy
Need for inotropes
Retinopathy of prematurity
Need for packed RBCs transfusion

Full Information

First Posted
November 3, 2018
Last Updated
May 15, 2022
Sponsor
Mansoura University Children Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03731546
Brief Title
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
Official Title
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Placental Insufficiency, Placental Transfusion
Keywords
Delayed cord clamping, Preterm Infant, Placental Insufficiency, Intrauterine growth restriction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
No Intervention
Arm Description
Placental insufficiency and ICC : Immediate cord clamping after delivery of the fetus in preterm infants with placental insufficiency
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Placental insufficiency and DCC: Cord clamping 60 seconds after delivery of fetus in preterm infants with placental insufficiency
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Normal placenta with DCC:Cord clamping 60 seconds after delivery of fetus in preterm infants without placental insufficiency
Intervention Type
Procedure
Intervention Name(s)
Delayed cord clamping
Intervention Description
Cord clamping 60 seconds after delivery of fetus in preterm infants
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 minutes 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 of infants' life
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
Time Frame
first 24 hours of infants' life
Title
Phototherapy requirements
Time Frame
first 28 days of life
Title
Polycythemia
Time Frame
first 28 days of life
Title
Culture proven sepsis
Time Frame
first 28 days of life
Title
Necrotizing enterocolitis
Time Frame
first 28 days of life
Title
Intraventricular hemorrhage
Time Frame
first 28 days of life
Title
Bronchopulmonary dysplasia
Time Frame
first 70 days of life
Title
Need for nasal CPAP
Time Frame
first 28 days of life
Title
Need for mechanical ventilation
Time Frame
first 28 days of life
Title
Duration of oxygen therapy
Time Frame
first 28 days of life
Title
Need for inotropes
Time Frame
first 28 days of life
Title
Retinopathy of prematurity
Time Frame
first 28 days of life
Title
Need for packed RBCs transfusion
Time Frame
first 28 days of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Minutes
Maximum Age & Unit of Time
1 Minute
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's Hospital
City
Mansourah
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21391876
Citation
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.
Results Reference
background
PubMed Identifier
23168790
Citation
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.
Results Reference
background
PubMed Identifier
32623628
Citation
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.
Results Reference
derived

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Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

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