NCT05492747

Brief Summary

Objectives: Kangaroo care is a safe and effective alternative method to conventional neonatal care for newborn babies. The aim of this study was to evaluate the effect of kangaroo care on the transition time to full oral feeding in preterm infants fed by gavage. Methods: This is a randomized controlled trial. This study was conducted in a level III neonatal intensive care unit of a university hospital in eastern Turkey 50 premature babies with a birth weight of ≥ 1000 g and a gestational age of 27-36 weeks, and their mothers were included in the study. The cases were randomly divided into two groups: kangaroo care, which would be applied up to five days a week, and standard care. Records of cases were kept regularly from their hospitalization until they reached full oral feeding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

25 days

First QC Date

July 25, 2022

Last Update Submit

August 26, 2022

Conditions

Keywords

Gavage feedingKangaroo careOral feedingPreterm babies

Outcome Measures

Primary Outcomes (1)

  • this study was measured the effects of kangaroo care in the transition period of preterm infants fed by gavage to full oral feeding.

    Transition from gavage feeding to full oral feeding: The first feeding of preterm babies is usually made through the orogastric tube due to the incomplete development of sucking and swallowing reflexes and the immaturity of the gastrointestinal tract. Accordingly, premature babies included in the study were fed with an orogastric tube after a certain period of time after their hospitalization. Recordings were made daily and continued until the transition to full oral feeding was achieved. Questionnaire for switching to full oral feeding: It is a questionnaire in which the date of transition to full feeding of preterm infants is written.

    3 weeks

Study Arms (1)

Kangaroo Care Effects on Feeding

EXPERIMENTAL

The researcher allocated the mothers blindly. Eligible mothers and their preterm babies were randomized to either the kangaroo care group or the standard care group (1:1) (Figure 1). The mothers' surnames were written and put in a bag. The surnames were drawn from the bag by lot. The lots were drawn by a neonatal nurse. Neonatal nurse is a research independent person. The first drawn surname was included in the kangaroo group, while the next one was included in the control group, respectively.

Other: Kangaroo Care an Effect

Interventions

Researchers evaluated vital signs and oxygen saturation of preterm infants in the kangaroo care group 15 minutes before kangaroo care. After the baby's mother was admitted to the NICU, she was assisted by the researcher for hand hygiene and they went to the incubator together. The mother was seated in a comfortable chair next to the incubator. After the researcher covered the head and back of the preterm baby with a baby blanket, she took it from the incubator and placed it between the mother's breasts, with the head up and upright. The baby was supported not only by the neck and shoulders, but also by the whole body. Skin contact between mother and baby was ensured at the highest level. The baby was positioned so that its lips were touching the mother's nipple. The researcher waited until the baby opened its mouth.

Kangaroo Care Effects on Feeding

Eligibility Criteria

Age27 Weeks - 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • parents who agreed to participate in the study

You may not qualify if:

  • healthy newborn
  • congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Didem Coşkun Şimşek

Elâzığ, 23000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2022

First Posted

August 8, 2022

Study Start

January 3, 2019

Primary Completion

January 28, 2019

Study Completion

November 5, 2019

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations