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NCT Number: NCT06821672

The Effect of Oral Feeding Model With a Chronobiological Approach in Neonates

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.

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Key information

Conditions

Preterm Behavior Bottle Feeding Chronobiology Chronobiology Disorders Communication Crying Dyssomnias Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Human Milk/Breastfeeding Mental Disorders Nervous System Diseases Nonverbal Communication Obstetric Labor Complications Obstetric Labor, Premature Occupational Diseases Pregnancy Complications Premature Birth Sleep Disorders, Circadian Rhythm Sleep Wake Disorders Urogenital Diseases

Age range

32 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Bilgi University

Şişli, Istanbul, 34387, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chronobiological Group

Procedure

In the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk.

Primary outcomes

  1. Sleep time

    Time frame: 24 hour

    Effect of Chronobiological Approach Feeding Model on infant sleep time during circadian matched breastfeeding sleep time in hours

  2. Crying time

    Time frame: 24 hour

    Effect of Chronobiological Approach Feeding Model on infant crying duration measured during circadian matched breastfeeding crying duration in hours

Secondary outcomes

  1. Discharge time

    Time frame: through study completion, an average of 30 days]

    The effect of Chronobiological Approach Nutrition Model application on infant's hospital stay

Sponsors and collaborators

Lead sponsor

Istanbul Bilgi University

Other

Registry information

Official study title

The Effect of Chronobiological Feeding Model on Sleep and Physiological Conditions of Neonates: A Randomized Controlled Study"

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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