Clinical trial NCT05802095: Effect of Supplemental Feeding Tube Devices in Breastfeeding Success and Mother's Breastfeeding Self-Efficacy
Official title: The Effect of Supplemental Feeding Tube Devices Used in Preterms on Baby's Breastfeeding Success and Mother's Breastfeeding Self-Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Feeding Disorder Neonatal
Keywords: neonatal feeding
breastfeeding
supplemental feeding tube device
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 32
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Clinical Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research will be carried out as a randomized controlled experimental design to evaluate the effectiveness of the breastfeeding support system to increase sucking success in premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers.

In the study, the experimental and control groups will be determined by randomization of premature babies hospitalized in the NICU. While the babies in the control group will be fed with the routine feeding method (bottle) of the NICU, the babies in the experimental group will be fed with the breastfeeding support system by their mother. Research data will be collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.

Detailed description: Premature babies have to cope with many problems in the neonatal intensive care unit (NICU) in the postnatal period, and feeding problems are the leading of these problems. Oral feeding of premature infants is a complex and dynamic process consisting of the interaction of oral-motor, neurological, cardiorespiratory and gastrointestinal systems. Because they are anatomically and physiologically immature, they often cannot coordinate their sucking, swallowing and respiration for oral feeding, and they often have difficulty in oral feeding. Therefore, feeding premature babies in the NICU is provided by an orogastric or nasogastric tube. Continuing the feeding with the gavage method for a long time causes a delay in the acquisition of the motor skills required for oral feeding. Therefore, premature babies should be switched to oral feeding when they are physiologically ready. It is known that growth and developmental retardation are seen in premature babies if appropriate and adequate nutrition is not provided on time.

The most basic criterion sought in the transition to oral feeding in premature babies is the development of feeding skills. Different oral stimulus interventions have been developed to support and strengthen the development of oral-motor functions, create sufficient suction power, and start oral nutrition earlier. Tactile/kinesthetic stimulation, oral stimulation, swallowing exercises, non-nutritive sucking, gentle pressure on the cheeks, lips, chin and palate are among the most common sensorimotor interventions. It is reported that these interventions accelerate the transition time to oral feeding. Successful sucking transition from gavage to full oral feeding is one of the most important determinants of both discharges from the NICU and the growth and development of premature infants. This study will evaluate the effect of the breastfeeding support system used in premature babies on the baby's sucking success and the mother's breastfeeding self-efficacy.

The research will be carried out as a randomized controlled experimental design to evaluate the effectiveness of the breastfeeding support system to increase sucking success in premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers.

In the study, the experimental and control groups will be determined by randomization of premature babies hospitalized in the NICU. While the babies in the control group will be fed with the routine feeding method (bottle) of the NICU, the babies in the experimental group will be fed with the breastfeeding support system by their mother. Research data will be collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.

Eligibility criteria: Inclusion Criteria:

1. Postmenstrual age 32 and 35 weeks of gestation,
2. Over 1500 g,
3. Switching to oral feeding after feeding with orogastric tube,
4. Who has been breastfed during gavage feeding,
5. Those who have not completed the first 24 hours in the transition from oragastric tube feeding to the oral feeding process,
6. Having cues of readiness for feeding (tolerating enteral nutrition, having a stable oxygen saturation and breathing during feeding, having the ability to lick, swallow and suck, react when mouth and lip are given stimuli),
7. The mother's willingness to breastfeed her baby,
8. Premature babies of parents who volunteered to participate in the study will be included.

Exclusion Criteria:

1. Having diseases other than being premature
2. Able to successfully take the breast in the first attempt,
3. Congenital anomaly,
4. Chromosomal disorders,
5. Having sepsis
6. With intracranial bleeding,
7. Those with a very low birth weight below 1500 g and
8. Less than 32nd gestational week,
9. Premature babies older than 35 weeks of gestation will be excluded.

Primary outcomes:
measure: LATCH a breastfeeding charting system and documentation tool
timeFrame: 1 hours
measure: Breastfeeding Self-Efficacy Short Form Scale
timeFrame: 1 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Şanlıurfa Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Harran University
name: Fatma Bozdağ
role: PRINCIPAL_INVESTIGATOR
References:
citation: Celik F, Sen S, Karayagiz Muslu G. Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants: A Randomized Controlled Trial. Clin Nurs Res. 2022 Jun;31(5):891-900. doi: 10.1177/10547738211058312. Epub 2021 Nov 16.