NCT04619459

Brief Summary

This study aims to determine the effect of kangaroo mother care (KMC) applied to the healthy newborns in the early postpartum period on breastfeeding. The results of the study are expected to contribute to promoting the practice of KMC in an effort to encourage breastfeeding not only in Turkey's hospitals but also in other developing countries where practices that negatively affect breastfeeding are prevalent. The hypotheses of the study were determined as: Infants administered KMC start to breastfeed sooner (H1), breastfeed more frequently (H2), breastfeed for longer periods (H3), are more successful at breastfeeding (H4) than infants receiving standard postpartum care (SPC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2016

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

October 29, 2020

Last Update Submit

November 4, 2020

Conditions

Keywords

Kangaroo Mother CareBreastfeedingPostpartum PeriodTerm NewbornMidwifery

Outcome Measures

Primary Outcomes (2)

  • LATCH Breastfeeding Assessment Tool

    The infants' suckling skills were assessed with this scale. The infants' suckling skills were assessed with the "LATCH Breastfeeding Assessment Tool" developed in 1994 by Jensen et al. and for which the validity and reliability testing of the Turkish version had been conducted by Yenal and Okumuş in 2003. The LATCH instrument comprises five parameters (Latch on breast, Audible swallowing, Type of nipple, Comfort breast/nipple, Hold/help) on which each item is assessed on the basis of 0-2. The highest possible score on the scale is 10; the lowest is 0.

    It was used in both groups before the first breastfeeding.

  • LATCH Breastfeeding Assessment Tool

    The infants' suckling skills were assessed with this scale. The infants' suckling skills were assessed with the "LATCH Breastfeeding Assessment Tool" developed in 1994 by Jensen et al. and for which the validity and reliability testing of the Turkish version had been conducted by Yenal and Okumuş in 2003. The LATCH instrument comprises five parameters (Latch on breast, Audible swallowing, Type of nipple, Comfort breast/nipple, Hold/help) on which each item is assessed on the basis of 0-2. The highest possible score on the scale is 10; the lowest is 0.

    After 24 hours the sucking ability of both groups was evaluated.

Study Arms (2)

Newborns receiving Kangaroo Mother Care (KMC)

EXPERIMENTAL

The newborns' diapers were tied, their caps put on and then they were positioned on their mother's naked chest for KMC. At Minute 5, the newborns' Apgar scores were assessed and recorded during KMC. The newborn's examination and injections (Hepatitis-B and K vit) were postponed until the first breastfeeding took place. A pediatrician performed a detailed examination of the newborns under the radiant infant warmer after the first breastfeeding. Following the examination, the newborn was positioned on the mother's breast for KMC. During this KMC, the newborn was administered 1 mg K vitamin in the right leg and 0.5 ml Hepatitis-B vaccine in the left leg via intramuscular injections. The KMC session was continued for 3 hours. Care attempt of mothers such as episiotomy repair was taken that the position of KMC.

Other: Kangaroo Mother Care (KMC)

Newborns receiving standard postpartum care (SPC):

NO INTERVENTION

He received the standard care of the hospital. KMC not applied.

Interventions

Kangaroo mother care is a method of care of infants. The method involves infants being carried, usually by the mother, with skin-to-skin contact. Kangaroo mother care (KMC). early after delivery have better success at breastfeeding and achieve this success sooner. In this method The newborns' diapers were tied, their caps put on and then they were positioned on their mother's naked chest for KMC. The KMC session was continued for 3 hours.

Newborns receiving Kangaroo Mother Care (KMC)

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe women were between the ages 18-42, had delivered normal vaginal birth
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy mothers
  • The women were between the ages 18-42,
  • Had delivered normal vaginal birth
  • Between gestational weeks 38-40
  • Consented to be a part of the study
  • Newborn being at term (in the 38th-42nd week), with a birthweight of 2500-4000 gr.
  • No serious case of asphyxiation in the newborn,
  • APGAR score of at least 7 at Minute 1 and Minute 5,
  • No health problem in the newborn to prevent it from breastfeeding

You may not qualify if:

  • Instrumental vaginal deliveries
  • Cesarean deliveries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevda Korkut Öksüz

Kırşehir, Bagbası, 40100, Turkey (Türkiye)

Location

Related Publications (7)

  • Inal S, Aydin Y, Canbulat N. Factors associated with breastfeeding initiation time in a baby-friendly hospital in Istanbul. Appl Nurs Res. 2016 Nov;32:26-29. doi: 10.1016/j.apnr.2016.03.008. Epub 2016 Apr 1.

    PMID: 27969039BACKGROUND
  • Thukral A, Sankar MJ, Agarwal R, Gupta N, Deorari AK, Paul VK. Early skin-to-skin contact and breast-feeding behavior in term neonates: a randomized controlled trial. Neonatology. 2012;102(2):114-9. doi: 10.1159/000337839. Epub 2012 Jun 14.

    PMID: 22699241BACKGROUND
  • Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

    PMID: 26869575BACKGROUND
  • Schiff DM, Wachman EM, Philipp B, Joseph K, Shrestha H, Taveras EM, Parker MGK. Examination of Hospital, Maternal, and Infant Characteristics Associated with Breastfeeding Initiation and Continuation Among Opioid-Exposed Mother-Infant Dyads. Breastfeed Med. 2018 May;13(4):266-274. doi: 10.1089/bfm.2017.0172. Epub 2018 Apr 9.

    PMID: 29630387BACKGROUND
  • Aghdas K, Talat K, Sepideh B. Effect of immediate and continuous mother-infant skin-to-skin contact on breastfeeding self-efficacy of primiparous women: a randomised control trial. Women Birth. 2014 Mar;27(1):37-40. doi: 10.1016/j.wombi.2013.09.004. Epub 2013 Nov 9.

    PMID: 24216342BACKGROUND
  • Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.

    PMID: 27885658BACKGROUND
  • Oksuz SK, Inal S. The effect of kangaroo mother care applied to the healthy newborns in the early postpartum period on breastfeeding: A randomized controlled trial. J Pak Med Assoc. 2021 Sep;71(9):2124-2129. doi: 10.47391/JPMA.376.

MeSH Terms

Conditions

Breast Feeding

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sevda K Öksüz, R.A

    Ahi Evran University Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 6, 2020

Study Start

June 1, 2016

Primary Completion

August 25, 2016

Study Completion

August 30, 2016

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

I did not find it appropriate to share it.

Locations