Improving oral feeding skills in preterm infants using a supplemental feeding system
The Effect of Supplemental Feeding System on Preterm Infants' Oral Feeding Skils: Randomized Controlled Trial
This study tests if a special feeding system can help preterm infants learn to feed better compared to regular bottle feeding in the neonatal intensive care unit.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 34 Weeks to 36 Weeks |
| Sex | All |
| Sponsor | Harran University Academic / other |
| Locations | 1 site (Sanlıurfa) |
| Trial ID | NCT05675891 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of a supplemental feeding system designed to enhance the early feeding skills of preterm infants in a neonatal intensive care unit. The study involves a randomized controlled design where preterm infants are assigned to either the experimental group using the supplemental feeding system or a control group using traditional bottle feeding. The infants' feeding skills are assessed based on physiological parameters and feeding performance during their transition to oral feeding. Data is collected on various metrics, including heart rate, oxygen saturation, and feeding times to determine the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants aged 34-36 weeks with a weight over 1500 grams who are transitioning from orogastric tube feeding to oral feeding.
Not a fit: Patients with additional health complications, congenital anomalies, or those who can successfully breastfeed on the first attempt may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the oral feeding abilities of preterm infants, leading to better nutritional outcomes.
How similar studies have performed: While this specific approach is novel, similar studies have shown promise in improving feeding skills in preterm infants using various supportive feeding methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenstrual age between 34-36 weeks (preterm babies at 34 and 36 weeks of gestation will be included), * Over 1500 g, * Switching to oral feeding after feeding with orogastric tube, * Breastfed during gavage feeding, * Those who have not completed the first 24 hours in the transition from orgastric tube feeding to the oral feeding process, * Having cues of readiness for feeding (tolerating enteral nutrition, having a stable oxygen saturation and respiration during feeding, having the ability to lick, swallow and suck, react when mouth and lip are given stimuli), * The mother's willingness to breastfeed her baby, * Preterm infants of parents who volunteered to participate in the study will be included. Exclusion Criteria: * Having diseases other than being preterm, * Capable of successfully taking the breast at the first attempt (Early Feeding Skill/EFS: 57), * With congenital anomaly, * With chromosomal disorders, * With sepsis, * With intracranial bleeding, * Those with a very low birth weight below 1500 g and * Preterm babies younger than 34 weeks of gestation will be excluded.
Where this trial is running
Sanlıurfa
- Harran University — Sanlıurfa, Turkey (Recruiting)
Study contacts
- Principal investigator: Fatma BOZDAĞ, Lecturer — Harran University
- Study coordinator: Fatma BOZDAĞ, Lecturer
- Email: fatmabozdag@harran.edu.tr
- Phone: +90 541 775 27 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.