Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes

NCT ID: NCT05849948

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-06-01

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.

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

choronobiological nutrition group

newborns were fed according to chronobiological nutrition

Group Type: EXPERIMENTAL

choronobiological nutrition

Intervention Type: BEHAVIORAL

Providing infant nutrition in accordance with crinobiological nutrition

control group

newborns will be fed in the order in which breastmilk is delivered to the hospital

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

choronobiological nutrition

Providing infant nutrition in accordance with crinobiological nutrition

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Ezgi Ayvaz

NURSE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ezgi Ayvaz

Role: CONTACT

ezgiayvz@gmail.com

05423787400

Other Identifiers

YENİDOĞAN DOKTORA TEZ

Identifier Type: -

Identifier Source: org_study_id