Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes

Sponsor

Eskisehir Osmangazi University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05849948

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutrition, Healthy	Behavioral: choronobiological nutrition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: choronobiological nutrition group newborns were fed according to chronobiological nutrition	Behavioral: choronobiological nutrition Providing infant nutrition in accordance with crinobiological nutrition
No Intervention: control group newborns will be fed in the order in which breastmilk is delivered to the hospital

Arm

Intervention/Treatment

Experimental: choronobiological nutrition group

newborns were fed according to chronobiological nutrition

Behavioral: choronobiological nutrition

Providing infant nutrition in accordance with crinobiological nutrition

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

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

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 Outcome Measures

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 discharge]
The newborn was evaluated in the first 6 months after discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Weeks to 36 Weeks

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Eskisehir Osmangazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ezgi Ayvaz, NURSE, Eskisehir Osmangazi University

ClinicalTrials.gov Identifier:

NCT05849948

Other Study ID Numbers:

YENİDOĞAN DOKTORA TEZ

First Posted:

May 9, 2023

Last Update Posted:

May 9, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ezgi Ayvaz, NURSE, Eskisehir Osmangazi University

premature

chorobiological nutrition

Breastfeeding Processes

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of May 9, 2023