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Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns

Primary Purpose

Infant, Newborn, Weight Loss

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kangaroo care training
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant, Newborn focused on measuring term newborn, weight loss, kangaroo care

Eligibility Criteria

undefined - 1 Week (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpasa Florence Nightingale School of NursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kangaroo care

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2021
Last Updated
August 4, 2021
Sponsor
Istanbul University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05001334
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Weight Loss
Keywords
term newborn, weight loss, kangaroo care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kangaroo care
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Kangaroo care training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physiological weight loss evaluation
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuray Dilek
Phone
+905533919281
Email
nevnuraydilek35@gmail.com
Facility Information:
Facility Name
Istanbul University-Cerrahpasa Florence Nightingale School of Nursing
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuray Dilek
Phone
+905533919281
Email
nevnuraydilek35@gmail.com
First Name & Middle Initial & Last Name & Degree
Nevin Hotun Sahin, Prof
Phone
+905337294337
Email
nevinsah@istanbul.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
If required participant information can be shared

Learn more about this trial

Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns

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