Clinical trial NCT05849948: Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes
Official title: The Effect of Chronobiological Nutritional Approach on Growth and Breastfeeding Processes of Premature Babies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition, Healthy
Keywords: premature
chorobiological nutrition
Breastfeeding Processes
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 94
Sex: ALL
Minimum age (years): 30
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: The change in the discharge time of newborns will be evaluated by using a questionnaire prepared by the researcher.
timeFrame: The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
Secondary outcomes:
measure: Weight gain of newborns will be evaluated using a questionnaire prepared by the investigator.
timeFrame: The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
Other outcomes:
measure: Height growth of newborns will be evaluated using a questionnaire prepared by the researcher.
timeFrame: The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
measure: Head circumference of newborns will be evaluated using a questionnaire prepared by the researcher.
timeFrame: The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
measure: The duration of breastfeeding of newborns by their mothers will be evaluated using a questionnaire prepared by the researcher.
timeFrame: will be evaluated once a month for 6 months after discharge
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