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
About this trial
This is an interventional other trial for Fetal Distress
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
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
NCT ID
NCT03859037
First Posted
February 11, 2019
Last Updated
February 27, 2019
Sponsor
Ain Shams University
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
Learn more about this trial
Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation
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