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The Effect of Oral Feeding Model With a Chronobiological Approach in Preterm Infants

NCT04992819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-08-05

No results posted yet for this study

Summary

As in healthy term babies, the ideal food for preterm infants and sick term babies is breast milk. There are many studies indicating that the composition of breast milk can vary from mother to mother, according to the gestational week of the baby and gender. In new researches on breast milk content; It is argued that breast milk is different during the day and at night, that the micro and macro nutrient content, hormones and some enzymes show different levels of secretion at different times of the day, and that breast milk has a circadian rhythm.

This research is designed as a prospective, randomized, controlled type. The study will be carried out in order to evaluate the effect of Chronobiological Approach Nutrition Model application on baby's growth parameters and discharge time in preterm babies hospitalized in Neonatal Intensive Care Unit (NICU).

Simple randomization method will be used for the study and the babies will be divided into intervention(n=40) and control groups(n=40). The research was carried out with 80 babies followed up in the neonatal intensive care unit.

The milk of the intervention group patients will be matched circadian and given to the babies, the milk of the control group patients will be given without matching according to the clinical routine practice. Demographic data, anthropometric measurements (weight, height, head circumference of all babies will be recorded in the "Baby Monitoring Form" created by the researcher.

Conditions

  • Breastfeeding
  • Bottle Feeding
  • Preterm
  • Chronobiology Disorders

Interventions

PROCEDURE

Chronobiological Approach Nutrition Model

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.

Sponsors & Collaborators

  • Okan University

    lead OTHER

Principal Investigators

  • Ebru Temizsoy · Zeynep Kamil Women and Child Diseases Training and Research Hospital. İstanbul, Turkey

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2021-07-03
Completion
2021-07-03

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04992819 on ClinicalTrials.gov