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Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU) (MIDAB-FU)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03681314
Recruitment Status : Not yet recruiting
First Posted : September 24, 2018
Last Update Posted : September 26, 2018
Sponsor:
Collaborators:
NPKSIMS, Nagpur, India
Sharp HealthCare
Information provided by (Responsible Party):
Zubair Aghai, Nemours Children's Clinic

Study Description
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Brief Summary:
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).

Condition or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Birth Asphyxia Other: Umbilical Cord Milking Not Applicable

Detailed Description:
The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either immediate cord clamping or umbilical cord milking as part of the MIDAB trial.
Masking: Single (Outcomes Assessor)
Masking Description: Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
Primary Purpose: Supportive Care
Official Title: Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Umbilical Cord Milking
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.
 Other: Umbilical Cord Milking
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.
No Intervention: Immediate Cord Clamping
The umbilical cord is clamped immediately after the delivery.


Outcome Measures
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Primary Outcome Measures :
  1. Neurodevelopmental Outcome at 2 Years of Age [ Time Frame: 22-26 months ]
    Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire


Secondary Outcome Measures :
  1. Fidgety Movements at 3 months of age [ Time Frame: 3-5 months ]
    Assessment of Fidgety Movements by Prechtl's method

  2. Neurodevelopmental Outcome at 1 Year of Age [ Time Frame: 10-14 months ]
    Developmental Activities Screening Inventory - Second Edition (DASI-II)

  3. Autism Outcome [ Time Frame: 22-26 months ]
    Modified Checklist for Autism in Toddlers (M-CHAT-R)


Eligibility Criteria
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Ages Eligible for Study:   3 Months to 26 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in MIDAB trial

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT03681314


Contacts
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Contact: Zubair Aghai, MD 215 955 6523 zaghai@nemours.org
Contact: Anup Katheria 858 839 4170 anup.katheria@sharp.com

Locations
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India
Daga Memorial Woman and Children Hospital
Nagpur, MS, India, 440002
Contact: Sarita Hazare, MD         
Principal Investigator: Sarita Hazare, MD         
Principal Investigator: Seema Parvekar, MD         
Government Medical College and Hospital
Nagpur, MS, India, 440009
Contact: Dipty Jain, MD       dipty47@rediffmail.com   
Principal Investigator: Dipty Jain, MD         
Principal Investigator: Juzar Fidvi, MD         
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Nagpur, MS, India, 440019
Contact: Meenakshi Girish, MD       meenakshimgirish@gmail.com   
Principal Investigator: Meenakshi Girish, MD         
Principal Investigator: Sulabha Joshi, MD         
Sponsors and Collaborators
Nemours Children's Clinic
NPKSIMS, Nagpur, India
Sharp HealthCare
Investigators
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Principal Investigator: Zubair Aghai, MD Nemours Children's Clinic
More Information
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Responsible Party: Zubair Aghai, Professor of Pediatrics, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03681314    
Other Study ID Numbers: UCM2018FU
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Asphyxia Neonatorum
Asphyxia
Central Nervous System Diseases
Nervous System Diseases
Hypoxia
Signs and Symptoms, Respiratory
 Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases