NCT06863753

Brief Summary

The primary aim of this study was to determine the effect of kangaroo mother care on breastfeeding success in the early postpartum period. The secondary aim was to determine the effect of kangaroo mother care on the vital signs of the mother and the baby.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 31, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

Same day

First QC Date

January 5, 2025

Last Update Submit

June 1, 2025

Conditions

Keywords

Kangaroo mother careBreastfeedingKangaroo careSkin-to-skin contact

Outcome Measures

Primary Outcomes (1)

  • LATCH Breastfeeding and Diagnostic Scale mean scores

    This measurement tool consists of five items. The name of the diagnostic tool, LATCH, is formed from the first letters of these five criteria in English. * L, Latch on the breast; * A, Audible swallowing; * T, Type of the nipple; * C, Comfort breast/nipple of the mother; * H, Hold/Help position of the baby. Each item is evaluated between 0-2 points. The total score that can be obtained from the scale is 10, and a high score means high breastfeeding success.

    Baseline and 60th minute

Secondary Outcomes (8)

  • Vital signs of babies

    Baseline and 60th minute

  • Vital signs of mothers

    Baseline and 60th minute

  • Vital signs of babies

    Baseline and 60th minute

  • Vital signs of babies

    Baseline and 60th minute

  • Vital signs of babies

    Baseline and 60th minute

  • +3 more secondary outcomes

Study Arms (2)

Kangaroo mother care

EXPERIMENTAL

The practice will take place in the mother and baby's room. Mother and baby will be prepared for the practice. Kangaroo mother care will be provided once, when the service, mother and baby are available, and then the practice will be performed. For skin-to-skin contact, the newborn will be laid naked on the mother's bare chest in the prone position, the newborn's abdomen and chest will be in contact with the mother's skin. Subsequently, the newborn's head will be turned to the side so that the airway remains open. The newborn will stay in this position for at least 45 minutes.

Other: Kangoroo mother care

Control

NO INTERVENTION

No intervention will be made to the control grup, only the data will be collected at the same time as the study group.

Interventions

Kangaroo mother care will be practiced once, when the service, mother and baby are available, and then the training will be given. For skin-to-skin contact, the newborn will be laid naked on the mother's bare chest in the prone position, the newborn's abdomen and chest will be in contact with the mother's skin. Subsequently, the newborn's head will be turned to the side so that the airway remains open. The newborn will stay in this position for at least 45 minutes.

Kangaroo mother care

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who gave birth
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years of age
  • Agree to participate in the survey (those who signed the Informed Consent Form)
  • Having had their first or second normal birth
  • Being literate
  • Having no communication problems
  • Being a singleton pregnancy
  • Having a gestational age of 37-42 weeks
  • Being open to communication and cooperation
  • Having an intact family unit
  • Birth weight 2500-4000 gr. between
  • Born by normal delivery
  • APGAR score of 7 and above at 1 and 5 minutes
  • No health problems or congenital anomalies
  • Born between 37 and 42 weeks of pregnancy

You may not qualify if:

  • Being under 18 years of age
  • Do not agree to participate in the study
  • Not being able to read or write
  • Having more than two babies
  • Having breast problems that prevent breastfeeding
  • Being born by Caesarean section
  • Having a diagnosed mental or psychological disorder
  • Weighing less than 2500 grams
  • Weighing more than 4000 grams
  • Being born by Caesarean section
  • APGAR score of less than 7 at 1 and 5 minutes
  • Being born with a congenital anomaly
  • Born before 37 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin Hospital

Mersin, Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In a randomized controlled experimental study, the mothers participating in the study and the person who will perform the statistical analysis will be masked. The researcher will not be masked. It will not be explained to the mothers which group they are in and it will be stated that kangaroo mother care and breastfeeding training will be provided.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, Clinical trial with randomized control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

January 5, 2025

First Posted

March 7, 2025

Study Start

May 31, 2025

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

June 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations