NCT05955404

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 10, 2023

Last Update Submit

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

EXPERIMENTAL

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

Interventions

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

Kangaroo mother care

Eligibility Criteria

Age32 Weeks - 37 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
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

Locations