The Effects of "Oral Administration of Breast Milk Droplets" and "Palatal Stimulation With a Finger"

NCT06447558 | Completed

• 1 other identifier: E-10840098-772.02-4979
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effects of "oral administration of breast milk droplets" and "finger palatal stimulation" on feeding tolerance in preterm neonates fed with orogastric tube feeding. This randomized controlled experimental study was conducted in the neonatal intensive care unit of a private hospital. The study included 90 premature newborns born at 28-36 weeks of gestation and admitted to the intensive care unit. The intervention group consisted of 60 infants and the control group consisted of 30 infants. "Demographic Information Form" and "Patient Follow-up Form" were used to collect data. Data collection tools were used before, during and after the procedures in all groups. In one of the intervention groups, breast milk droplets were applied to the oral cavity of the newborns, and in the other group, the palate of the newborns was stimulated using a finger. These interventions were performed for 5 minutes every 3 hours for 7 days during the newborns' feeding times. Neonates in the control group were fed with an orogastric tube by following hygiene rules, but no study intervention was performed in these infants. SPSS (Statistical Package for Social Sciences) 22.0 for Windows software was used for statistical analysis.

Conditions

Infants

Keywords

Breast milk; Palatal stimulation with a finger

Outcome Measures

Primary Outcomes (4)

• Defecation

  The number of daily defecations was monitored

  7 days

• Residual control

  Daily residue count was monitored

  7 days

• Body weight

  Body weight checked daily

  7 days

• Abdominal circumference measurement

  Abdominal circumference was measured daily

  7 days

Study Arms (3)

Breast milk droplets group

NO INTERVENTION

We fed the infants via OGT in the oral administration of breast milk droplets group after applying a total of 0.5 cc of breast milk in drops into their mouths for 5 minutes by using an insulin injector.Breast milk droplets group was 30 infants

Palatal stimulation group

OTHER

In the palatal stimulation group, following the necessary hygiene rules, we used the little finger of one of our hands with a glove on and stimulated the palate and gums of the infants with this finger by slow and peristalsis-like movements for 5 minutes while the infants were fed via OGT. Palatal stimulation group was 30 infants.

Behavioral: palatal stimulation with a finger in premature infants

Control group

NO INTERVENTION

We fed the premature infants in the control group via OGT following all hygiene rules, but we performed no intervention. In the intervention groups, where we orally applied breast milk in droplets in one group and stimulated the palate of the newborns by using a finger in the other, we performed these interventions every 3 hours for 5 minutes for 7 days at feeding times.

Interventions

palatal stimulation with a finger in premature infants BEHAVIORAL

Oral administration of breast milk droplets, palatal stimulation with a finger in premature infants

Palatal stimulation group

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Babies born between 28-36 weeks of birth
• Premature babies without major congenital anomalies, severe systemic disorders, NEC, suspected or confirmed sepsis diagnosis
• Premature babies whose vital importance is fixed
• Babies who were not intubated at the time of the research

You may not qualify if:

• Babies younger than 28 weeks of birth and older than 36 weeks of birth
• Premature babies with major congenital anomalies, severe systemic disorders, NEC, suspected or confirmed sepsis diagnosis
• Premature babies whose vital features are unstable
• Babies who were intubated at the time of the research
• Babies who do not have parental permission to work

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Study Officials

• Aysel Kokcu Dogan

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: June 7, 2024
• Study Start: May 1, 2021
• Primary Completion: March 25, 2022
• Study Completion: June 28, 2022
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)