The Effect of Oral Feeding Model With a Chronobiological Approach in Preterm Infants

NCT ID: NCT04992819

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-29
• Study Completion Date: 2021-07-03

Brief Summary

As in healthy term babies, the ideal food for preterm infants and sick term babies is breast milk. There are many studies indicating that the composition of breast milk can vary from mother to mother, according to the gestational week of the baby and gender. In new researches on breast milk content; It is argued that breast milk is different during the day and at night, that the micro and macro nutrient content, hormones and some enzymes show different levels of secretion at different times of the day, and that breast milk has a circadian rhythm.

This research is designed as a prospective, randomized, controlled type. The study will be carried out in order to evaluate the effect of Chronobiological Approach Nutrition Model application on baby's growth parameters and discharge time in preterm babies hospitalized in Neonatal Intensive Care Unit (NICU).

Simple randomization method will be used for the study and the babies will be divided into intervention(n=40) and control groups(n=40). The research was carried out with 80 babies followed up in the neonatal intensive care unit.

The milk of the intervention group patients will be matched circadian and given to the babies, the milk of the control group patients will be given without matching according to the clinical routine practice. Demographic data, anthropometric measurements (weight, height, head circumference of all babies will be recorded in the "Baby Monitoring Form" created by the researcher.

Detailed Description

Circadian fluctuations in breast milk content are very important in preterm infants fed with expressed breast milk. The composition of breast milk varies throughout the day. In the literature, there is no randomized controlled study suggesting that the breast milk of infants fed with expressed milk should be matched to the baby circadian. In this study, it was aimed to evaluate the effect of Chronobiological Approach Model application on preterm infants growth parameters and discharge time in feeding of preterm infants hospitalized in the neonatal intensive care unit . It is aimed to accelerate the growth of babies by making circadian matching to breast milk in feeding preterm infants and to increase the quality of nursing practices by reducing the length of hospital stay.

Conditions

Breastfeeding; Bottle Feeding; Preterm; Chronobiology Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

Preterm infants in NICU are fed with breast milk and bottle. Although the date is written on expressed breast milk, it is usually not given by checking its suitability for the time of day. Experiment is about labeling breast milk by time of day before giving it to babies. There is no extra intervention during feeding. The breastmilk of the control group patients will be given without matching according to the clinical routine practice.

Demographic data, anthropometric measurements (weight, height, head circumference of all babies will be recorded in the "Baby Monitoring Form" created by the researcher.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chronobiological Approach Nutrition Model

Preterm infants in NICU are fed with breast milk and bottle. Although the date is written on expressed breast milk, it is usually not given by checking its suitability for the time of day. The milk of the intervention group patients will be matched circadian and given to the babies. Intervention group's breast milk is labeling by time of day before the each feeding. In the intervention group, a label containing the time of expressed breastmilk will be affixed. Circadian matched milk will be provided at each feeding.

intervention is;n the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk.

Demographic data, anthropometric measurements (weight, height, head circumference of all babies will be recorded in the "Baby Monitoring Form" created by the researcher.

Group Type: EXPERIMENTAL

Chronobiological Approach Nutrition Model

Intervention Type: PROCEDURE

In the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk.

Interventions

Chronobiological Approach Nutrition Model

In the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Birth weight >1400 <2500 gram and gestational week ≥32-37 weeks
• Who are feeding only human milk
• Fully enterally fed babies (50-100ml / kg / day)
• Whose parents signed the informed consent to participate in the study were included.

Exclusion Criteria

• Infants who cannot feed with human milk
• Who receive intravenous fluid, total parenteral nutrition or mixed fluid
• Infants with major congenital, cardiac, respiratory or airway abnormalities and infants who require additional pressure and respiratory support
• Metabolic imbalances, hypoglycemia or electrolyte imbalance
• Narcotic analgesic or sedation therapy
• Whose parents did not sign the informed consent were excluded.

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Okan University

OTHER

Sponsor Role: lead

Responsible Party

Ebru Temizsoy

Princiciple İnvestigator, RN, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Temizsoy

Role: PRINCIPAL_INVESTIGATOR

Zeynep Kamil Women and Child Diseases Training and Research Hospital. İstanbul, Turkey

Locations

Zeynep Kamil Women and Child Diseases Training and Research Hospital.

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

25848687

Identifier Type: -

Identifier Source: org_study_id