Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes

Not Applicable

Not yet recruiting

• Conditions: Nutrition, Healthy
• Interventions: Behavioral: choronobiological nutrition

• Registration Number: NCT05849948
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

The aim of this study is to determine the effect of chronobiological nutrition approach on the growth and breastfeeding processes of premature babies. It will be carried out in a randomized controlled experimental design. In the study, it is planned to have 2 groups as experimental and control. As a result of the power analysis using the G Power 3.0.10 program, 90% power; A total of at least 78 samples were found to be sufficient in the study with a 5% margin of error (n1: 39; n2: 39). However, considering that the case could be lost, it was decided to increase it by 20% to 94 babies. Infants will be assigned to groups using a stratified sequential block randomization method. Premature babies will be stratified by week of gestation, birth weight and sex, and then an equal number of babies will be assigned to each group by blocking.

The appointment of premature infants will be decided by sequential block randomization.

After the descriptive information of the babies assigned to the groups is recorded in the questionnaire, the experimental group will be fed by applying the chronobiological nutrition approach. The control group will be fed without applying the chronobiological nutrition approach. The discharge times will be calculated for both groups.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-28
• Last Update Submitted: 2023-04-28
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09
• Study Start: 2023-06-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Being treated in the NICU
• Gestation week is between 30 and 36
• The delivery took place in the hospital where the study was conducted.
• 70% of the daily enteral feeding is done with breast milk

Exclusion Criteria

• The baby is less than 30 weeks of gestation and greater than 36 weeks of gestation.
• Having neurological sequelae
• Having Grade 4 intraventricular bleeding
• The development of problems such as sepsis, NEC, which may change the general condition
• Being followed in invasive mechanical ventilation
• Receiving narcotic analgesics and sedation
• The baby has been shipped from outside
• Having undergone gastrointestinal (GIS) surgery or having GIS anomaly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
choronobiological nutrition group	choronobiological nutrition	newborns were fed according to chronobiological nutrition

Primary Outcome Measures

Name	Time	Method
The change in the discharge time of newborns will be evaluated by using a questionnaire prepared by the researcher.	The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.	newborn was evaluated during hospital treatment

Secondary Outcome Measures

Name	Time	Method
Weight gain of newborns will be evaluated using a questionnaire prepared by the investigator.	The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.	newborn was evaluated during hospital treatment