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

NCT06821672 | Completed

• 1 other identifier: 2023/0161
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Chronobiology; Human Milk/Breastfeeding; Bottle Feeding; Sleep Disorders, Circadian Rhythm

Keywords

preterm Human milk Circadian rhythm neonate, sleep, cry

Outcome Measures

Primary Outcomes (2)

• Sleep time

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

  24 hour

• Crying time

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

  24 hour

Secondary Outcomes (1)

• Discharge time

  through study completion, an average of 30 days]

Study Arms (2)

Control group

NO INTERVENTION

No Intervention: Control Group Preterm infants in the NICU are fed with breast milk and bottles. Although the date is written on the expressed breast milk, it is usually not given after checking the time of day. The experiment is about labeling the breast milk according to the time of day before giving it to the babies. No extra intervention is made during feeding. The breast milk of the control group patients will be given without being matched according to the clinical routine practice. Demographic data, measurements of sleep characteristics (time and quality), and characteristics of physiological status will be recorded on the "Baby Monitoring Form" created by the researcher.

Intervention Group

EXPERIMENTAL

Experimental: Chronobiological Approach Nutrition Model Preterm infants in NICU are fed with breast milk and bottle. Although the date is written on expressed breast milk, it is usually not given by checking its suitability for the time of day. The milk of the intervention group patients will be matched circadian and given to the babies. Intervention group's breast milk is labeling by time of day before the each feeding. In the intervention group, a label containing the time of expressed breastmilk will be affixed. Circadian matched milk will be provided at each feeding. intervention is;n 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. Demographic data, measurements of sleep characteristics (duration and quality), and characteristics of physiological status will be recorded on the "Baby Monitoring Form"

Procedure: Chronobiological Group

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Istanbul Bilgi University

Şişli, Istanbul, 34387, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Bottle Feeding; Sleep Disorders, Circadian Rhythm; Crying

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior; Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Nonverbal Communication; Communication

Study Officials

• ebru temizsoy, PhD

  İstanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN

Model Details: Randomized Controlled two groups (control group and study group)

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: December 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: May 15, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)