Effect of Kangaroo Care on Test Weighing

NCT04252547 | Recruiting DMC

• 1 other identifier: 10840098-604.01.01-E.53511
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Kangaroo Care; Weight Gain; Oxygen Saturation; Heart Rate

Keywords

kangaroo care; test weighing; Heart rate; oxygen saturation; preterm infants

Outcome Measures

Primary Outcomes (1)

• 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.

  Change the body weight before feeding to after feeding at 1 day

Secondary Outcomes (2)

• Heart Rate

  Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding

• Oxygen Saturation

  Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feeding

Study Arms (2)

Grup 1

EXPERIMENTAL

-"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.

Other: Kangaroo Care; Other: Control

Grup 2

EXPERIMENTAL

\- "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.

Other: Kangaroo Care; Other: Control

Interventions

Kangaroo Care OTHER

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.

Grup 1; Grup 2

Control OTHER

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.

Grup 1; Grup 2

Eligibility Criteria

• Age: 32 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Agreeing to participate in the study for parents.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Weight Gain

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Duygu Gözen, Assoc. Prof.

  Istanbul University Cerrahpaşa Florence Nightingale Faculty of Nursing

  PRINCIPAL INVESTIGATOR

• Ayhan Taştekin, prof.

  Istanbul Medipol University, Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Canan Genç, BSN

CONTACT

(0216) 910 19 07; cananuzun5561@gmail.com

Duygu Gözen, Assoc. Prof.

CONTACT

dgozen@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, Principal Investigator

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: February 5, 2020
• Study Start: June 9, 2024
• Primary Completion: September 9, 2025
• Study Completion: January 9, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-01

Locations

TU (1)