The Effect of Bed Head Height During Feeding With Orogastric Catheter on Neonatal Growth
1 other identifier
interventional
96
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2024
CompletedFirst Submitted
Initial submission to the registry
May 10, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedJuly 23, 2025
July 1, 2025
5 months
May 10, 2025
July 14, 2025
Conditions
Keywords
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°
EXPERIMENTALIn 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.
Group with Bed Head Height 45°
EXPERIMENTALThe 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.
Control Group
NO INTERVENTIONThe 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.
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.
Eligibility Criteria
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)
Related Publications (5)
Özkan, H. (2016). Preterm ve Term Yenidoğanda Büyümenin Değerlendirilmesi. Klinik Tıp Pediatri Dergisi, 83-87.
BACKGROUNDÖzge Karakaya Suzan, N. Ç. (2020). Kolostrum: Özellikleri ve Prematüre Bebeğe Faydaları. Sted, 221-227
BACKGROUNDBozkurt, G., Sönmez Düzkaya D. (2015). Enteral Beslenme Uygulama Protokolü. Yenidoğan Protokolleri (s. 157-159). içinde İstanbul: Nobel Tıp Kitabevleri.
BACKGROUNDDemet Terek, M. Y. (2019). Yenidoğan Bebeğin Beslenmesinde Temel Prensipler. Klinik Tıp Pediatri Dergisi, 233-244.
BACKGROUNDAysel Gürkan, B. G. (2013). Enteral Beslenme: Bakımda Güncel Yaklaşımlar Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 116-122
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tarsus University
Tarsus University
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