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Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes

The Effect of Chronobiological Nutritional Approach on Growth and Breastfeeding Processes of Premature Babies

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05849948
Enrollment
94
Registered
2023-05-09
Start date
2023-06-01
Completion date
2024-06-01
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition, Healthy

Keywords

premature, chorobiological nutrition, Breastfeeding Processes

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.

Interventions

BEHAVIORALchoronobiological nutrition

Providing infant nutrition in accordance with crinobiological nutrition

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Weeks to 36 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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

Other

MeasureTime frameDescription
Height growth of newborns will be evaluated 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
Head circumference of newborns will be evaluated 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
The duration of breastfeeding of newborns by their mothers will be evaluated using a questionnaire prepared by the researcher.will be evaluated once a month for 6 months after dischargeThe newborn was evaluated in the first 6 months after discharge.

Contacts

Primary ContactEzgi Ayvaz
ezgiayvz@gmail.com05423787400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026