Clinical trial NCT05001334: Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant, Newborn
Weight Loss
Keywords: term newborn
weight loss
kangaroo care
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2021-08-11
Enrollment: 102
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Physiological weight loss evaluation
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa Florence Nightingale School of Nursing
Study officials:
References: