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

February 27, 2019 updated by: Ahmed Atef Elbeltagy, Ain Shams University
Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Immediate cord claming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure mean blood pressure
Time Frame: Changes of all data will be assessed every 30seconds for ten minutes
Measure mean blood pressure in mmhg
Changes of all data will be assessed every 30seconds for ten minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure heart rate
Time Frame: Heart rate will be assessed every 30 seconds for 10 minuets
Measure heart rate in beat/minutes
Heart rate will be assessed every 30 seconds for 10 minuets

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2019

Primary Completion (ANTICIPATED)

March 30, 2019

Study Completion (ANTICIPATED)

April 10, 2019

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (ACTUAL)

March 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AinshamsU12345
  • Aaaaaa (REGISTRY: Ahmed)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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