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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05955404
Other study ID # kangroo mother care
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2022
Est. completion date February 28, 2023

Study information

Verified date July 2023
Source University of Baghdad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 32 Weeks to 37 Weeks
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Iraq College of Nursing- The University of Baghdad Baghdad

Sponsors (1)

Lead Sponsor Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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