The Effect of Breast Milk Odor on Feeeding in Preterm Infants

NCT06563973 | Completed DMC

• 1 other identifier: 2022/0715
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted as a randomized controlled experiment to assess the impact of breast milk odor, applied before the first oral feeding of preterm infants transitioning to oral feeding, on their feeding performance. Infants in the neonatal intensive care unit who were beginning oral feeding were randomly assigned to one of two groups through computer randomization. In the "pacifier" group, infants were given a pacifier for 3 minutes one hour before feeding and again for 2 minutes 10 minutes before feeding to support oral feeding. In contrast, the "breast milk odor and pacifier" group received 2 cc of breast milk, which was dripped onto a sterile sponge and placed about 3 cm from the infant's nose one hour before feeding. At feeding time, all infants in both groups were bottle-fed by the researcher. This marked their first experience with oral feeding. The infants' feeding skills and performance were then evaluated using the Early Feeding Skills (EFS) form during the feeding session.

Conditions

Bottle Feeding; Preterm İnfant

Keywords

Feeding Performance; Preterm Infants; Milk Odor

Outcome Measures

Primary Outcomes (3)

• Early Feeding Skills

  An observer nurse, who was not part of the research team, evaluated the infant's feeding skills using the Early Feeding Skills (EFS) Evaluation Form.

  during feeding up to 1 hour

• The feeding duration (Feeding performance)

  The infant's feeding performance was assessed by calculating the feeding duration. To measure feeding time, a stopwatch on a phone was activated at the start of feeding and stopped once feeding concluded.

  immediately after feeding

• Feeding performance

  The infant's feeding performance was assessed by calculating the amount of food consumed per minute. The total amount of food the infant consumed (in cc) was then compared to the amount prescribed by the doctor.

  immediately after feeding

Study Arms (2)

Breast milk odor and pacifier group

EXPERIMENTAL

A pacifier was given for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding to support oral feeding. In contrast to the control group, 2 cc of breast milk was dripped onto a sterile sponge one hour before feeding and placed in the baby's incubator, close to the nose (3 cm away). Heart rate and oxygen saturation levels were recorded 10 minutes before feeding.

Other: Milk odor; Other: Pacifier

Pacifier group

ACTIVE COMPARATOR

A pacifier was provided for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding to support oral feeding. Heart rate and oxygen saturation levels were recorded 10 minutes prior to feeding.

Other: Pacifier

Interventions

Milk odor OTHER

One hour before feeding time, 2 cc of breast milk was dripped onto a sterile sponge and placed inside the baby's incubator, close to the baby's nose (3 cm).

Breast milk odor and pacifier group

Pacifier OTHER

To support oral feeding, a pacifier was given for 3 minutes one hour before feeding time and for 2 minutes 10 minutes before feeding time.

Breast milk odor and pacifier group; Pacifier group

Eligibility Criteria

• Age: 26 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• parents must give voluntary consent to participate; the infant must have been born between 26 and 34 weeks of gestation, as determined by the mother's last menstrual period; at the time of the study, the infant must be more than 30 weeks postmenstrual; the infant must be transitioning from enteral to oral feeding for the first time; the infant must be free of health issues other than prematurity; the infant must be fed with the mother's milk; the physician must have approved the infant's readiness for oral feeding; the infant must exhibit physiological and behavioral signs that indicate readiness for oral feeding.

You may not qualify if:

• severe bronchopulmonary dysplasia; any gastrointestinal, neurological, or genetic disorder (such as necrotizing enterocolitis, intracranial hemorrhage, hydrocephalus, omphalocele, Down syndrome, gastroschisis); any condition that could interfere with oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial anomaly).

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Fenerbahce University

Istanbul, İ̇stanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bottle Feeding; Premature Birth

Interventions

Pacifiers

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Infant Equipment; Equipment and Supplies

Study Officials

• Duygu Gözen, Prof.

  Koç University

  PRINCIPAL INVESTIGATOR

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: Research Assistant

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: April 18, 2023
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)