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Kangroo Mother Care

Primary Purpose

Preterm Birth Complication

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Kangaroo mother care
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Birth Complication

Eligibility Criteria

32 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • College of Nursing- The University of Baghdad

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kangaroo mother care

Arm Description

This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.

Outcomes

Primary Outcome Measures

Premature Infant Pain Profile-Revised (PIPP-R)
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.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2023
Last Updated
July 18, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05955404
Brief Title
Kangroo Mother Care
Official Title
Effect of Kangaroo Mother Care in Alleviating Preterm Infant's Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth Complication

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kangaroo mother care
Arm Type
Experimental
Arm Description
This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
Intervention Type
Other
Intervention Name(s)
Kangaroo mother care
Intervention Description
This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
Primary Outcome Measure Information:
Title
Premature Infant Pain Profile-Revised (PIPP-R)
Description
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.
Time Frame
Two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
College of Nursing- The University of Baghdad
City
Baghdad
ZIP/Postal Code
14149
Country
Iraq

12. IPD Sharing Statement

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Kangroo Mother Care

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