Kangroo Mother Care
Effect of Kangaroo Mother Care in Alleviating Preterm Infant's Pain
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedFirst Submitted
Initial submission to the registry
July 10, 2023
CompletedFirst Posted
Study publicly available on registry
July 21, 2023
CompletedJuly 21, 2023
July 1, 2023
4 months
July 10, 2023
July 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Two months
Study Arms (1)
Kangaroo mother care
EXPERIMENTALThis study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
Interventions
This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
College of Nursing- The University of Baghdad
Baghdad, 14149, Iraq
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 10, 2023
First Posted
July 21, 2023
Study Start
November 2, 2022
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
July 21, 2023
Record last verified: 2023-07