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Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes

E

Eskisehir Osmangazi University

Status

Not yet enrolling

Conditions

Nutrition, Healthy

Treatments

Behavioral: choronobiological nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT05849948
YENİDOĞAN DOKTORA TEZ

Details and patient eligibility

About

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.

Enrollment

94 estimated patients

Sex

All

Ages

30 to 36 weeks old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

94 participants in 2 patient groups

choronobiological nutrition group
Experimental group
Description:
newborns were fed according to chronobiological nutrition
Treatment:
Behavioral: choronobiological nutrition
control group
No Intervention group
Description:
newborns will be fed in the order in which breastmilk is delivered to the hospital

Trial contacts and locations

0

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Central trial contact

Ezgi Ayvaz

Data sourced from clinicaltrials.gov

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