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Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation

Primary Purpose

Fetal Distress

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Umbilical cord milking
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fetal Distress

Eligibility Criteria

28 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • babies who need resuscitation
  • Preterm babies with 28-34 weeks gestatinal age

Exclusion Criteria:

  • preterm babies above 34 weeks gestational age, -- -
  • refusal by mother or obestatracain, -- -babies with congenital anomalies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Umbilical cord milking

    Immediate cord clamping

    Arm Description

    One group will have umbilical cord milking and will ba assessed for blood pressure,oxygen saturation and heart rate by monitor

    One group will have immediate cord clamping and will be assessed for bloob pressure,heart rate,oxygen saturation by monitor

    Outcomes

    Primary Outcome Measures

    measure mean blood pressure
    Measure mean blood pressure in mmhg

    Secondary Outcome Measures

    Measure heart rate
    Measure heart rate in beat/minutes

    Full Information

    First Posted
    February 11, 2019
    Last Updated
    February 27, 2019
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03859037
    Brief Title
    Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation
    Official Title
    Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2019 (Anticipated)
    Primary Completion Date
    March 30, 2019 (Anticipated)
    Study Completion Date
    April 10, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    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
    Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not
    Detailed Description
    Investigators will make milking for 100 preterm babies and placed them on warmer and assess heart rate,blood pressure,oxygen saturation,fio2,maximum pip,PEEP and 100 babies other without milking to see the difference between two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fetal Distress

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups,one will have umbilical cord milking and other will have immediate cord clamping ,two groups will put on warmer after birth and blood pressure,heart rate ,oxygen saturation will be assessed by monitor every 30 seconds up to 10 minutes
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Umbilical cord milking
    Arm Type
    Experimental
    Arm Description
    One group will have umbilical cord milking and will ba assessed for blood pressure,oxygen saturation and heart rate by monitor
    Arm Title
    Immediate cord clamping
    Arm Type
    Placebo Comparator
    Arm Description
    One group will have immediate cord clamping and will be assessed for bloob pressure,heart rate,oxygen saturation by monitor
    Intervention Type
    Other
    Intervention Name(s)
    Umbilical cord milking
    Other Intervention Name(s)
    Immediate cord claming
    Intervention Description
    100 babies will have squeezing of blood from umbilical cord towards baby
    Primary Outcome Measure Information:
    Title
    measure mean blood pressure
    Description
    Measure mean blood pressure in mmhg
    Time Frame
    Changes of all data will be assessed every 30seconds for ten minutes
    Secondary Outcome Measure Information:
    Title
    Measure heart rate
    Description
    Measure heart rate in beat/minutes
    Time Frame
    Heart rate will be assessed every 30 seconds for 10 minuets

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Weeks
    Maximum Age & Unit of Time
    34 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: babies who need resuscitation Preterm babies with 28-34 weeks gestatinal age Exclusion Criteria: preterm babies above 34 weeks gestational age, -- - refusal by mother or obestatracain, -- -babies with congenital anomalies

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation

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