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Effect of Kangaroo Care on Test Weighing

Primary Purpose

Kangaroo Care, Weight Gain, Oxygen Saturation

Status
Suspended
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kangaroo Care
Control
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kangaroo Care focused on measuring kangaroo care, test weighing, Heart rate, oxygen saturation, preterm infants

Eligibility Criteria

32 Weeks - 40 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Agreeing to participate in the study for parents.

The inclusion criteria for infants were as follows;

  • Attaining to oral feeding by the physician in the neonatal intensive care unit
  • Being born at 26-36+6 gestational week which is determined according to the mother's last period cycle
  • Being at 32-39+6 postmenstrual week during the time they are included in the study
  • Having body weight of 1500 grams and above
  • Being breastfed at least once
  • Having no health problems other than being preterm

Exclusion Criteria:

The exclusion criteria for infants were as follows;

  • Suffering from gastrointestinal, neurological or genetic diseases (such as necrotizing enterocolitis, intracranial bleeding, hydrocephalia, omphalocele, down syndrome, gastroschisis) and other diseases
  • Having a condition obstructing oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial abnormalities etc.)
  • Receiving oxygen support

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Grup 1

Grup 2

Arm Description

-"During the Procedure" Group 1 The preprocedural measurements(weight, heart rate and oxygen saturation ) will be applied to the infants in Group 1 before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. During the second feeding hour, his/her heart rate and oxygen saturation will begin to be recorded ten minutes before the feeding hour. The data will be recorded for ten minutes and then the infant will be taken out of the incubator and weight is measured only in his/her clean diaper. He/she will be handed over to the mother to breastfeed.

- "During the Procedure" Group 2 The preprocedural measurements will be applied to the infants in Group 2 before the first feeding hour when they are included in the study and then they will be breastfed by their mothers. The preprocedural measurements (weight, heart rate and oxygen saturation) will be applied to the infant during the second feeding hour and then he/she will be held on his/her mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother.

Outcomes

Primary Outcome Measures

Test Weighing
The infants' body weight before and after feeding will be measured using an 'Infant Scale'. The infants will be weighed naked only in their diaper before and after feeding, in order to evaluate the amount of milk they have received from their mothers' breast.

Secondary Outcome Measures

Heart Rate
A device branded "Masimo Brand Radical 7 Pulse Oximetry" will be used to determine the infants' oxygen saturation and pulse rate. Heart rate of all the infants in Group 1 and Group 2 will begin to be recorded ten minutes before the first and second feeding hours when they are included in the study.
Oxygen Saturation
A device branded "Masimo Brand Radical 7 Pulse Oximetry" will be used to determine the infants' oxygen saturation and pulse rate. Oxygen Saturation of all the infants in Group 1 and Group 2 will begin to be recorded ten minutes before the first and second feeding hours when they are included in the study.

Full Information

First Posted
January 9, 2020
Last Updated
October 6, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04252547
Brief Title
Effect of Kangaroo Care on Test Weighing
Official Title
The Effect Of Kangaroo Mother Care On Test Weighing In Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Data cannot be collected due to Covid-19.
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
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 study will be conducted with the Crossover Randomized Controlled Method. The infants who have attained oral feeding in the neonatal intensive care unit will be divided into two groups via randomization in the computer environment. After the randomization, kangaroo care will be applied to the infants in Group 1 during the first feeding hour when they are included in the study and they will be breastfed by their mothers without any other application during the next feeding. On the other hand, no application will be performed on the infants in Group 2 during the first feeding hour when they are included in the study and kangaroo care will be applied to them during the second feeding hour. The infants in both groups will be breastfed by their mothers during the feeding hours.
Detailed Description
Test weighing is a feeding evaluation method which is used for evaluating the increase in infant's body weight and the amount of food intake before and after breastfeeding. Each gram is evaluated to be equivalent to one cc breast milk. The aim of the study is to evaluate the effect of kangaroo care applied to the preterm infants that have attained oral feeding and are breastfed by their mothers, on their physiological parameters, feeding condition and body weight increase. After weighing the infant only in his/her diaper before the feeding and applying kangaroo care in which skin-to-skin contact will be provided for half an hour, the mother will breastfeed the infant. The infant will be weighed once again after the feeding without diaper change and the effect of kangaroo care on test weighing and physiological parameters during the feeding process will be evaluated. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 23 for each group and 46 in total. Parents of the infants meeting the study inclusion criteria will be informed both in written and verbally and then the study will be conducted with mothers who agree to participate in the study with their infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kangaroo Care, Weight Gain, Oxygen Saturation, Heart Rate
Keywords
kangaroo care, test weighing, Heart rate, oxygen saturation, preterm infants

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Grup 1
Arm Type
Experimental
Arm Description
-"During the Procedure" Group 1 The preprocedural measurements(weight, heart rate and oxygen saturation ) will be applied to the infants in Group 1 before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. During the second feeding hour, his/her heart rate and oxygen saturation will begin to be recorded ten minutes before the feeding hour. The data will be recorded for ten minutes and then the infant will be taken out of the incubator and weight is measured only in his/her clean diaper. He/she will be handed over to the mother to breastfeed.
Arm Title
Grup 2
Arm Type
Experimental
Arm Description
- "During the Procedure" Group 2 The preprocedural measurements will be applied to the infants in Group 2 before the first feeding hour when they are included in the study and then they will be breastfed by their mothers. The preprocedural measurements (weight, heart rate and oxygen saturation) will be applied to the infant during the second feeding hour and then he/she will be held on his/her mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother.
Intervention Type
Other
Intervention Name(s)
Kangaroo Care
Intervention Description
The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. A chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. The infant's heart rate and oxygen saturation will also continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weight is measured without a diaper change and his/her weight will be recorded. Then he/she will be taken back in the incubator to sleep.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before feeding when they are included in the study and then they will be breastfed by their mothers. The chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. Also, the infant's heart rate and oxygen saturation will continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weighed without a diaper change and his/her weight will be recorded. When the care process is over, it will be taken back in the incubator to sleep.
Primary Outcome Measure Information:
Title
Test Weighing
Description
The infants' body weight before and after feeding will be measured using an 'Infant Scale'. The infants will be weighed naked only in their diaper before and after feeding, in order to evaluate the amount of milk they have received from their mothers' breast.
Time Frame
Change the body weight before feeding to after feeding at 1 day
Secondary Outcome Measure Information:
Title
Heart Rate
Description
A device branded "Masimo Brand Radical 7 Pulse Oximetry" will be used to determine the infants' oxygen saturation and pulse rate. Heart rate of all the infants in Group 1 and Group 2 will begin to be recorded ten minutes before the first and second feeding hours when they are included in the study.
Time Frame
Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding
Title
Oxygen Saturation
Description
A device branded "Masimo Brand Radical 7 Pulse Oximetry" will be used to determine the infants' oxygen saturation and pulse rate. Oxygen Saturation of all the infants in Group 1 and Group 2 will begin to be recorded ten minutes before the first and second feeding hours when they are included in the study.
Time Frame
Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feeding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
40 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Agreeing to participate in the study for parents. The inclusion criteria for infants were as follows; Attaining to oral feeding by the physician in the neonatal intensive care unit Being born at 26-36+6 gestational week which is determined according to the mother's last period cycle Being at 32-39+6 postmenstrual week during the time they are included in the study Having body weight of 1500 grams and above Being breastfed at least once Having no health problems other than being preterm Exclusion Criteria: The exclusion criteria for infants were as follows; Suffering from gastrointestinal, neurological or genetic diseases (such as necrotizing enterocolitis, intracranial bleeding, hydrocephalia, omphalocele, down syndrome, gastroschisis) and other diseases Having a condition obstructing oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial abnormalities etc.) Receiving oxygen support
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duygu Gözen, Assoc. Prof.
Organizational Affiliation
Istanbul University Cerrahpaşa Florence Nightingale Faculty of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayhan Taştekin, prof.
Organizational Affiliation
Istanbul Medipol University, Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Effect of Kangaroo Care on Test Weighing

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