Clinical trial NCT06821672: The Effect of Oral Feeding Model With a Chronobiological Approach in Neonates
Official title: The Effect of Chronobiological Feeding Model on Sleep and Physiological Conditions of Neonates: A Randomized Controlled Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Chronobiology
Human Milk/Breastfeeding
Bottle Feeding
Sleep Disorders, Circadian Rhythm
Keywords: preterm Human milk Circadian rhythm neonate, sleep, cry
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled two groups (control group and study group)
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Circadian fluctuations in breast milk content are very important in preterm infants fed with breast milk. The composition of breast milk changes throughout the day. There is no randomized controlled study in the literature suggesting that breast milk should be matched to the infant's circadian. This study aimed to evaluate the effect of the Chronobiological Nutrition Model application on the sleep characteristics and physiological conditions of preterm infants in the neonatal intensive care unit. It is aimed to increase the sleep duration and depth of infants, shorten the crying periods and increase the quality of nursing practices by circadian matching with breast milk in the feeding of preterm infants.

Eligibility criteria: Inclusion Criteria:

* Infants with family consent,
* 32 0/6 - 36 6/7 weeks of gestation,
* Exclusively breastfed,
* Infants who have switched to full oral feeding

Exclusion Criteria:

* Intravenous fluid therapy,
* Feeding intolerance
* Sepsis, Necrotizing enterocolitis, Major congenital anomaly,
* Mechanical ventilation support.

Primary outcomes:
measure: Sleep time
timeFrame: 24 hour
measure: Crying time
timeFrame: 24 hour
Secondary outcomes:
measure: Discharge time
timeFrame: through study completion, an average of 30 days]
Other outcomes:
Locations:
city: Sisli
country: Turkey
facility: Istanbul Bilgi University
state: Istanbul
Study officials:
affiliation: İstanbul Bilgi University
name: ebru temizsoy, PhD
role: PRINCIPAL_INVESTIGATOR
References: