Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fetal Distress