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

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ClinicalTrials.gov Identifier: NCT03859037
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Atef Elbeltagy, Ain Shams University

Brief Summary:
Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not

Condition or disease Intervention/treatment Phase
Fetal Distress Other: Umbilical cord milking Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Investigator)
Primary Purpose: Other
Official Title: Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : April 10, 2019

Arm Intervention/treatment
Experimental: Umbilical cord milking
One group will have umbilical cord milking and will ba assessed for blood pressure,oxygen saturation and heart rate by monitor
Other: Umbilical cord milking
100 babies will have squeezing of blood from umbilical cord towards baby
Other Name: Immediate cord claming

Placebo Comparator: Immediate cord clamping
One group will have immediate cord clamping and will be assessed for bloob pressure,heart rate,oxygen saturation by monitor
Other: Umbilical cord milking
100 babies will have squeezing of blood from umbilical cord towards baby
Other Name: Immediate cord claming




Primary Outcome Measures :
  1. measure mean blood pressure [ Time Frame: Changes of all data will be assessed every 30seconds for ten minutes ]
    Measure mean blood pressure in mmhg


Secondary Outcome Measures :
  1. Measure heart rate [ Time Frame: Heart rate will be assessed every 30 seconds for 10 minuets ]
    Measure heart rate in beat/minutes



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Ages Eligible for Study:   28 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Ahmed Atef Elbeltagy, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03859037    
Other Study ID Numbers: AinshamsU12345
Aaaaaa ( Registry Identifier: Ahmed )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
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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Fetal Distress