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NCT06821672
The Effect of Oral Feeding Model With a Chronobiological Approach in Neonates
NA trial testing Chronobiological Group in Preterm in 60 participants. Completed in 15 May 2024.
20 December 2023
Quick facts
| Lead sponsor | Istanbul Bilgi University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 20 December 2023 |
| Primary completion | 20 December 2023 |
| Estimated completion | 15 May 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Chronobiological Group
Conditions studied
- Preterm — all drugs for Preterm →
- Chronobiology — all drugs for Chronobiology →
- Human Milk/Breastfeeding — all drugs for Human Milk/Breastfeeding →
- Bottle Feeding — all drugs for Bottle Feeding →
Sponsor
Istanbul Bilgi University
Who can join
Adults 32 Weeks to 37 Weeks, any sex, with Preterm or Chronobiology. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The ideal food for healthy term babies as well as preterm babies and sick term babies is breast milk. There are many studies showing that the composition of breast milk can vary from mother to mother, according to the baby's gestational age and gender. New studies on the content of breast milk suggest that breast milk is different during the day and at night, that micro and macronutrient content, hormones and some enzymes are secreted at different levels at different times of the day and that breast milk has a circadian rhythm. This study was designed as a prospective, randomized, controlled study. The study will be conducted to evaluate the effect of the Chronobiological Approach Feeding Model application on the baby's sleep characteristics and physiological conditions in preterm babies hospitalized in the Neonatal Intensive Care Unit (NICU). The simple randomization method will be used in the study and the babies will be divided into intervention (n=30) and control (n=30) groups. The study was conducted with 60 infants followed in the neonatal intensive care unit. The milk of the intervention group patients will be given to the babies by matching them circadianly , while the milk of the control group patients will be given without matching according to clinical routine practice. Demographic data and sleep measurements (time and quality) of all infants will be recorded in the "Baby Monitoring Form" created by the researcher.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06821672
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06821672 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istanbul Bilgi University
- Last refreshed: 12 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06821672.
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