Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns

Sponsor
Istanbul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05001334
Collaborator
Istanbul University-Cerrahpasa (Other)
102
1
2
28
3.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Kangaroo care training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
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
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Physiological weight loss evaluation [1 week]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 1 Week
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University-Cerrahpasa Florence Nightingale School of Nursing Istanbul Turkey

Sponsors and Collaborators

  • Istanbul University
  • Istanbul University-Cerrahpasa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nuray Dilek, Nurse, MSc, Istanbul University
ClinicalTrials.gov Identifier:
NCT05001334
Other Study ID Numbers:
  • Kanguru
First Posted:
Aug 11, 2021
Last Update Posted:
Aug 11, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nuray Dilek, Nurse, MSc, Istanbul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2021