NCT07079878

Brief Summary

Aim:The study was planned as a randomised controlled experimental study to determine the effect of bed head height applied during feeding with orogastric catheter on growth parameters and feeding tolerance of preterm newborns. Method: The study was a randomised controlled experimental study. The sample of the study consisted of 96 newbornMethod: The study was a randomised controlled experimental study. The sample of the study consisted of 96 preterm newborns (control: 32, Group with 30° Bed Head Height: 32, Group with 45° Bed Head Height: 32) ). Data Collection Form was used as a data collection tool. The head of the newborns in the intervention group will be raised before the orogastric catheter is inserted, and the children in the control group will be routinely positioned. In this process, physiological parameters of newborns before and after positioning will be followed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

May 10, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

pretermoragastrik beslenmebeslenmepozisyon

Outcome Measures

Primary Outcomes (2)

  • Newborn Information Form

    The information form was prepared by reviewing the relevant literature (Özdel, 2017). The neonatal information form includes 14 items including mode of delivery, 1st and 5th minute APGAR score, gestational age, birth weight, birth weight, birth head circumference, birth length, gender, mother's history of any disease during pregnancy, hospitalisation diagnosis, postnatal age, weight, height and head circumference at the time of assessment.This form will be used to identify the newborn. The average values will be calculated based on age (in days), weight (in kg), and height (in cm).

    1 day

  • Newborn Monitoring Form

    The follow-up form was prepared based on a review of the relevant literature (Özdel, 2017; Yüce 2020). In the newborn follow-up form, vital signs such as body temperature (Celsius), heart rate (beats per minute), respiratory rate (breaths per minute) and oxygen saturation (percentage) will be measured in the morning and evening for 7 days, and abdominal distension, abdominal circumference measurement (cm), and vomiting status will be assessed in terms of feeding tolerance, while parameters such as weight (in kilograms), head circumference (in cm), and height (in cm) will be assessed for growth monitoring over a 7-day period. The data obtained will be used to evaluate the babies' feeding.

    1 day

Study Arms (3)

Group with Bed Head Height 30°

EXPERIMENTAL

In the preterm newborn lying in the neonatal intensive care unit, the bed head height is adjusted to 30° 30 minutes before feeding and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. All data will be evaluated by the investigator and recorded on the intervention monitoring form.

Other: Group with Bed Head Height 30°

Group with Bed Head Height 45°

EXPERIMENTAL

The head of the bed of the preterm newborn lying in the neonatal intensive care unit is adjusted to 45° 30 minutes before feeding and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. All data will be evaluated by the investigator and recorded on the intervention monitoring form.

Other: Group with Bed Head Height 45°

Control Group

NO INTERVENTION

The bed head height of the preterm newborn lying in the neonatal intensive care unit is adjusted in accordance with the clinical routine (15°) and vital signs are monitored 30 minutes before feeding. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. All data will be evaluated by the investigator and recorded on the intervention monitoring form.

Interventions

30 minutes before feeding, the bed head height of the preterm newborn is adjusted to 30° and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days.

Group with Bed Head Height 30°

The bed head height of the preterm newborn is adjusted to 45° 30 minutes before feeding and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days.

Group with Bed Head Height 45°

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The newborn should be in the 32-36th postnatal week
  • The weight of the newborn should be over 1500 grams
  • The newborn should be able to meet at least 75% of the protein and energy amount that he/she should take through the enteral route
  • The newborn should be fed with an orogastric catheter
  • The newborn should not need a mechanical ventilator
  • The newborn should not have a congenital anomaly
  • The parents should volunteer to participate in the study.

You may not qualify if:

  • Neonates with NEC
  • Newborns whose bedhead height cannot be provided due to any condition
  • Previous findings of feeding intolerance
  • Having a chest tube
  • Parents not volunteering to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (5)

  • Özkan, H. (2016). Preterm ve Term Yenidoğanda Büyümenin Değerlendirilmesi. Klinik Tıp Pediatri Dergisi, 83-87.

    BACKGROUND
  • Özge Karakaya Suzan, N. Ç. (2020). Kolostrum: Özellikleri ve Prematüre Bebeğe Faydaları. Sted, 221-227

    BACKGROUND
  • Bozkurt, G., Sönmez Düzkaya D. (2015). Enteral Beslenme Uygulama Protokolü. Yenidoğan Protokolleri (s. 157-159). içinde İstanbul: Nobel Tıp Kitabevleri.

    BACKGROUND
  • Demet Terek, M. Y. (2019). Yenidoğan Bebeğin Beslenmesinde Temel Prensipler. Klinik Tıp Pediatri Dergisi, 233-244.

    BACKGROUND
  • Aysel Gürkan, B. G. (2013). Enteral Beslenme: Bakımda Güncel Yaklaşımlar Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 116-122

    BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Tarsus University

    Tarsus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 10, 2025

First Posted

July 23, 2025

Study Start

July 5, 2024

Primary Completion

December 5, 2024

Study Completion

December 5, 2024

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations