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Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731546
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Nehad Nasef, 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.

Condition or disease Intervention/treatment Phase
Preterm Infant Placental Insufficiency Placental Transfusion Procedure: Delayed cord clamping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Peripheral venous CD34 at admission [ Time Frame: 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 :
  1. Admission hemoglobin [ Time Frame: 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.

  2. Hemoglobin at 2 months [ Time Frame: 2 months of infants' life ]
    One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life.

  3. Admission platelets [ Time Frame: 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.

  4. Admission WBCs [ Time Frame: first 24 hours of infants' life ]
    One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24

  5. Phototherapy requirements [ Time Frame: first 28 days of life ]
  6. Polycythemia [ Time Frame: first 28 days of life ]
  7. Culture proven sepsis [ Time Frame: first 28 days of life ]
  8. Necrotizing enterocolitis [ Time Frame: first 28 days of life ]
  9. Intraventricular hemorrhage [ Time Frame: first 28 days of life ]
  10. Bronchopulmonary dysplasia [ Time Frame: first 70 days of life ]
  11. Need for nasal CPAP [ Time Frame: first 28 days of life ]
  12. Need for mechanical ventilation [ Time Frame: first 28 days of life ]
  13. Duration of oxygen therapy [ Time Frame: first 28 days of life ]
  14. Need for inotropes [ Time Frame: first 28 days of life ]
  15. Retinopathy of prematurity [ Time Frame: first 28 days of life ]
  16. Need for packed RBCs transfusion [ Time Frame: first 28 days of life ]


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Ages Eligible for Study:   up to 1 Minute   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731546


Locations
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Egypt
Mansoura University Children's Hospital
Mansourah, Egypt
Sponsors and Collaborators
Mansoura University Children Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nehad Nasef, Professor of pediatrics/Neonatology, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT03731546    
Other Study ID Numbers: MS/17.04.15
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nehad Nasef, Mansoura University Children Hospital:
Delayed cord clamping
Preterm Infant
Placental Insufficiency
Intrauterine growth restriction
Additional relevant MeSH terms:
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Premature Birth
Placental Insufficiency
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases