CClinicalTrials.gg
Status unknownNCT05001334Updated Aug 11, 2021

Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns

An interventional study of Kangaroo care training in Infant, Newborn and Weight Loss, sponsored by Istanbul University. Status unknown at 1 site in Turkey. Open to participants aged Up to 1 Week, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-11.

Sponsored by Istanbul University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Sep 2020, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
Up to 1 Week
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Infant, Newborn
  • Weight Loss

Keywords

  • term newborn
  • weight loss
  • kangaroo care
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's planned enrollment of 102 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 1 Week
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralKangaroo 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — If required participant information can be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05001334
Lead sponsor
Istanbul University
Collaborators
Istanbul University - Cerrahpasa
Responsible party
Nuray Dilek (Nurse, MSc, Istanbul University) — Principal investigator
First posted
Aug 11, 2021
Start date
Sep 1, 2020
Primary completion
Sep 30, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 11, 2021

Study contacts

Nuray Dilek
Contact
nevnuraydilek35@gmail.com
+905533919281

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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