Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns

NCT ID: NCT05001334

Last Updated: 2021-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant, Newborn Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Kangaroo care training

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nuray Dilek

Nurse, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpasa Florence Nightingale School of Nursing

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nuray Dilek

Role: CONTACT

+905533919281

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nuray Dilek

Role: primary

+905533919281

Nevin Hotun Sahin, Prof

Role: backup

+905337294337

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Kanguru

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.