Impact of a Chronobiologic Feeding Model on Newborn Circadian Rhythm
Effect of Chronobıologıcal Approach Feedıng Model on Cırcadıan Rhythm, Growth and Physıologıcal Parameters in Newborn: A Randomızed Controlled Study
This study is testing if a special feeding schedule for newborns can help improve their sleep patterns and growth during those important early weeks of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 28 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | Selcuk University Academic / other |
| Locations | 2 sites (Kirsehir and 1 other locations) |
| Trial ID | NCT05923437 on ClinicalTrials.gov |
What this trial studies
This study evaluates how a feeding model based on chronobiology affects the circadian rhythm, growth, and physiological parameters in newborns. It focuses on the critical early weeks of life when establishing a healthy sleep pattern is essential for the development of the circadian rhythm. The study will involve newborns receiving breast milk at regular intervals, aiming to understand how this feeding approach influences their sleep-wake cycles and overall development. The research highlights the importance of nutrition and environmental factors in shaping newborns' circadian rhythms.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns with a gestational age between 28-42 weeks, stable health conditions, and who are exclusively breastfed at 3-hour intervals.
Not a fit: Patients who may not benefit from this study include those with congenital anomalies, central nervous system dysfunction, or those requiring resuscitation.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how feeding practices influence the circadian rhythm and overall health of newborns.
How similar studies have performed: While there is limited research on the relationship between circadian rhythm and breast milk, this study aims to fill a gap in existing literature, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age between 28-42 weeks * Birth weight between 1500 and 4200 gr * Hospitalization for at least 3 days * Exclusive breastfeeding (oral/ enteral) * Feeding at 3-hour intervals * Stable health condition * Spontaneous breathing Exclusion Criteria: * Babies fed outside of 3-hour intervals (hourly or two-hourly intervals) * 5th minute apgar score below 4 at the time of delivery * Resuscitation requirement * Having a congenital anomaly * Interventional intervention in the head region * Central nervous system dysfunction * Postpartum medical complications
Where this trial is running
Kirsehir and 1 other locations
- Kirsehir Ahi Evran University — Kirsehir, Turkey (Recruiting)
- Selcuk University — Konya, Turkey (Recruiting)
Study contacts
- Principal investigator: Sibel Kucukoglu — Selcuk University
- Study coordinator: Sibel Kucukoglu
- Email: s_nadaroglu@hotmail.com
- Phone: +903322231623
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.