Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns

Evaluating the Efficiency of Kangaroo Care on Physiological Weight Loss in Term Newborns by Means of Number of Feedings, Number of Diapers and Periodic Weight Measurements

The aim of the study is to evaluate the effect of kangaroo care on physiological weight loss in term newborns.

Study Overview

• Status: Recruiting
• Conditions: Weight Loss; Infant, Newborn
• Intervention / Treatment: Behavioral: Kangaroo care training

Detailed Description

The data collection process continues in a randomized controlled experimental study conducted to determine the effect of kangaroo care on physiological weight loss in term newborns. In the calculation made for the determined effect size, 80% power, 5% margin of error and one-way statistical significance, the experimental group was planned as 51 and the control group as 51 newborns. In this reporting period, 25 newborns as the experimental group and 30 newborns as the control group were followed up and interviewed with the mother.

Mothers who meet the criteria to participate in the research are informed about the research in the delivery room or in the first hours of delivery. The mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to.

Breastfeeding of the mother, the number and frequency of bottle feeding, kangaroo care, diuresis, defecation numbers and weight are recorded by following up. Physiological weight losses are determined by comparing birth weight with daily weight losses.

A cotton kangaroo care blanket is given to every mother who agrees to participate in the study, so that mothers can care for their kangaroos comfortably and to continue kangaroo care at home. These covers, prepared for kangaroo care, increase the motivation of mothers to participate in the study. In order to facilitate the follow-up of diuresis and defecation numbers, the family is supported in the evaluation of diapers (number, weight).

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nuray Dilek; Phone Number: +905533919281; Email: nevnuraydilek35@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul University-Cerrahpasa Florence Nightingale School of Nursing
    • Contact: Nuray Dilek; Phone Number: +905533919281; Email: nevnuraydilek35@gmail.com
    • Contact: Nevin Hotun Sahin, Prof; Phone Number: +905337294337; Email: nevinsah@istanbul.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Term babies born between 37-42 weeks of gestation
• Newborns born vaginally
• Newborns with developed sucking and swallowing reflexes

Exclusion Criteria:

• Newborns born with C-section
• Newborns in need of NICU care
• Preterm newborns (born <37 weeks of gestation)
• Newborns in need of oxygen
• Genetic or metabolic disease (of the baby) limiting breastfeeding
• HIV (+) mother
• Mother having a chronic disease that will affect breastfeeding
• Mother using drugs that pass into the breastmilk and affect the baby
• Presence of a medical problem that will prevent the mother and baby from staying together

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kangaroo care; The mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to.	Behavioral: Kangaroo care training; During perinatal period, mothers are given extra training (other than routine newborn care) about kangaroo care. Baby-mother diad is called for weight check-ups.
No Intervention: Control group; The mothers of the control group who accept to participate in the research are NOT given any extra training other than routine breastfeeding and care of a newborn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological weight loss evaluation	Physiological weight loss of term newborns whose mothers are trained about and perform kangaroo care, is theorised to be less than those who receive standard newborn care information. Periodical weight measurements will be recorded. To evaluate feeding efficiency, number of feedings and kangaroo care periods, changed diaper numbers will be evaluated.	1 week

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: weight loss; kangaroo care; term newborn
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: Kanguru

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If required participant information can be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No