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Completed

NCT Number: NCT05955404

Kangroo Mother Care

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.

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Key information

Conditions

Preterm Birth Complication

Age range

32 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Nursing- The University of Baghdad

Baghdad, 14149, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kangaroo mother care

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2023
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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