Kangroo Mother Care

July 18, 2023 updated by: Hiba Abdulwahid Dawood, University of Baghdad

Effect of Kangaroo Mother Care in Alleviating Preterm Infant's Pain

infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs and comparing the pain intensity with preterm infants who receive conventional care.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq, 14149
        • College of Nursing- The University of Baghdad

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Preterm infants whose corrected gestational age from (32 - <37) weeks of pregnancy
  • Preterm infants who do not experience any painful procedure for last 24 hours
  • Preterm infants do not receive any sedation for last 24 hours

Exclusion Criteria:

  • full-term infants whose corrected gestational age is >37 weeks
  • extremely preterm (< 28 weeks)
  • very preterm (28-<32 weeks)
  • proven or suspected sepsis
  • major congenital malformations
  • all heart defect except neonatal Patent ductus arteriosus (PDA)
  • necrotizing enterocolitis
  • neurodevelopmental disability
  • who receive respiratory support {Mechanical Ventilation, Continuous Positive Airway Pressure, or high-flow support
  • indicated for surgery
  • contraindication to oral sucrose
  • Twins
  • infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kangaroo mother care
This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
Other: Kangaroo mother care
This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature Infant Pain Profile-Revised (PIPP-R)
Time Frame: Two months
The Premature Infant Pain Profile-Revised (PIPP-R) measures the intensity of pain that the preterm infants experience in NICU through infant indicators (change in heart rate from baseline, decrease in oxygen saturation from baseline, browse bulge, eye squeeze, and naso-labial furrow. It also includes gestational age and behavioral state.
Two months

Collaborators and Investigators

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

Sponsor

University of Baghdad

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 (Actual)

November 2, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kangroo mother care

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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