The Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction

NCT05888090 | Completed

• 1 other identifier: 14311537094
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a PhD dissertation. In this study, the investigators aim to investigate the effects of three different positions after feeding on gastric residual volume, abdominal oxygenation using near infrared spectroscopy (NIRS), and fractional oxygen extraction values in preterm newborns.

Conditions

Gastric Residual Volume; Abdominal Oxygenation; Fractional Oxygen Extraction; Positioning (Prone, Right Lateral and Semi-Elevated Supine Position)

Keywords

Preterm Infants; Positioning; Gastric Residual Volume; Abdominal Oxygenation; Fractional Oxygen Extraction

Outcome Measures

Primary Outcomes (3)

• Preterm newborn abdominal NIRS value

  Average NIRS values will be calculated for periods immediately before, during and after feeding. NIRS values will be recorded by the device, after the monitoring, the picture of the records will be taken from the device.

  Preterm newborns whose feedings are every two hours will be monitored for 6 hours and those whose feedings are every three hours will be monitored for 9 hours. Preterm newborns will be monitored for a total of three feedings

• Fractional oxygen extraction value

  Pulse oximeter and NIRS monitor will be used together to determine fractional oxygen extraction.

  Preterm newborns whose feedings are every two hours will be monitored for 6 hours and those whose feedings are every three hours will be monitored for 9 hours. Preterm newborns will be monitored for a total of three feedings

• Gastric residual volume

  Gastric residual volume will be checked manually using a 5 ml syringe prior to feeding. Gastric residue will be excreted or given back in consultation with the doctor according to its amount and color.

  Preterm newborns whose feedings are every two hours will be monitored for 6 hours and those whose feedings are every three hours will be monitored for 9 hours. Preterm newborns will be monitored for a total of three feedings

Study Arms (3)

Intervention Group 1

EXPERIMENTAL

Other: Prone, right lateral, and semi-elevated supine positions

Intervention Group 2

EXPERIMENTAL

Other: Semi-elevated supine, prone, and right lateral positions

Intervention Group 3

EXPERIMENTAL

Other: Right lateral, semi-elevated supine, and prone positions

Interventions

Prone, right lateral, and semi-elevated supine positions OTHER

Each participant will be followed during three feedings and the prone, right lateral, and semi-elevated supine positions will be applied once.

Intervention Group 1

Semi-elevated supine, prone, and right lateral positions OTHER

Each participant will be followed during three feedings and the semi-elevated supine, prone, and right lateral positions will be applied once.

Intervention Group 2

Right lateral, semi-elevated supine, and prone positions OTHER

Each participant will be followed during three feedings and the right lateral, semi-elevated supine, and prone positions will be applied once.

Intervention Group 3

Eligibility Criteria

• Age: 28 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm newborns who are at 28-33 weeks of gestation according to the last menstrual period of the mother,
• Preterm newborns who are breastfed,
• Preterm newborns who are clinically stable and enteral feeding started,
• Preterm newborns who are first enteral nutrition 24 hours after mechanical ventilation,
• Preterm newborns who are at least 50% of their nutrition provided with enteral nutrition,
• Free Newborns fed by flow and orogastric tube and with informed consent of the parents will be included in the study.

You may not qualify if:

• Preterm newborns requiring mechanical ventilation,
• Preterm newborns diagnosed with NEC,
• Preterm newborns vomiting,
• Preterm newborns who have abdominal distension,
• Preterm newborns who have nasal mechanical obstruction,
• Preterm newborns who have congenital anomalies,
• Preterm newborns who have gastrointestinal problems such as gastroschisis or congenital diaphragmatic hernia,
• Preterm newborn who have cerebrovascular disease, apnea episodes, severe neurological disease, were included in the study. will not be included,

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Hande Özgörü

Merkez, Isparta, 32000, Turkey (Türkiye)

Location

Related Publications (23)

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  PMID: 30386758 BACKGROUND

• Braski K, Weaver-Lewis K, Loertscher M, Ding Q, Sheng X, Baserga M. Splanchnic-Cerebral Oxygenation Ratio Decreases during Enteral Feedings in Anemic Preterm Infants: Observations under Near-Infrared Spectroscopy. Neonatology. 2018;113(1):75-80. doi: 10.1159/000481396. Epub 2017 Nov 8.

  PMID: 29131125 BACKGROUND

• Barsan Kaya T, Aydemir O, Tekin AN. Prone versus supine position for regional cerebral tissue oxygenation in preterm neonates receiving noninvasive ventilation. J Matern Fetal Neonatal Med. 2021 Oct;34(19):3127-3132. doi: 10.1080/14767058.2019.1678133. Epub 2019 Oct 15.

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• Chen SS, Tzeng YL, Gau BS, Kuo PC, Chen JY. Effects of prone and supine positioning on gastric residuals in preterm infants: a time series with cross-over study. Int J Nurs Stud. 2013 Nov;50(11):1459-67. doi: 10.1016/j.ijnurstu.2013.02.009. Epub 2013 Mar 26.

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• Corvaglia L, Martini S, Battistini B, Rucci P, Aceti A, Faldella G. Bolus vs. continuous feeding: effects on splanchnic and cerebral tissue oxygenation in healthy preterm infants. Pediatr Res. 2014 Jul;76(1):81-5. doi: 10.1038/pr.2014.52. Epub 2014 Apr 8.

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• Corvaglia L, Martini S, Battistini B, Rucci P, Faldella G, Aceti A. Splanchnic Oxygenation at First Enteral Feeding in Preterm Infants: Correlation With Feeding Intolerance. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):550-554. doi: 10.1097/MPG.0000000000001308.

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• Cortez J, Makker K, Kraemer DF, Neu J, Sharma R, Hudak ML. Maternal milk feedings reduce sepsis, necrotizing enterocolitis and improve outcomes of premature infants. J Perinatol. 2018 Jan;38(1):71-74. doi: 10.1038/jp.2017.149. Epub 2017 Sep 28.

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• da Costa CS, Greisen G, Austin T. Is near-infrared spectroscopy clinically useful in the preterm infant? Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F558-61. doi: 10.1136/archdischild-2014-307919. Epub 2015 Jul 27.

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• Demirel G, Oguz SS, Celik IH, Erdeve O, Dilmen U. Cerebral and mesenteric tissue oxygenation by positional changes in very low birth weight premature infants. Early Hum Dev. 2012 Jun;88(6):409-11. doi: 10.1016/j.earlhumdev.2011.10.005. Epub 2011 Nov 15.

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• Dani C, Coviello C, Montano S, Remaschi G, Petrolini C, Strozzi MC, Maggiora E, Sabatini M, Gazzolo D. Effect on splanchnic oxygenation of breast milk, fortified breast milk, and formula milk in preterm infants. Pediatr Res. 2021 Jan;89(1):171-174. doi: 10.1038/s41390-020-0935-1. Epub 2020 May 7.

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• Garvey AA, Dempsey EM. Applications of near infrared spectroscopy in the neonate. Curr Opin Pediatr. 2018 Apr;30(2):209-215. doi: 10.1097/MOP.0000000000000599.

  PMID: 29369068 BACKGROUND

• Goldshtrom N, Isler JR, Sahni R. Comparing liver and lower abdomen near-infrared spectroscopy in preterm infants. Early Hum Dev. 2020 Dec;151:105194. doi: 10.1016/j.earlhumdev.2020.105194. Epub 2020 Sep 17.

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• Hay WW Jr, Hendrickson KC. Preterm formula use in the preterm very low birth weight infant. Semin Fetal Neonatal Med. 2017 Feb;22(1):15-22. doi: 10.1016/j.siny.2016.08.005. Epub 2016 Aug 30.

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• Liao SM, Rao R, Mathur AM. Head Position Change Is Not Associated with Acute Changes in Bilateral Cerebral Oxygenation in Stable Preterm Infants during the First 3 Days of Life. Am J Perinatol. 2015 Jun;32(7):645-52. doi: 10.1055/s-0034-1390348. Epub 2014 Oct 5.

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• Martini S, Aceti A, Beghetti I, Faldella G, Corvaglia L. Feed-related Splanchnic Oxygenation in Preterm Infants With Abnormal Antenatal Doppler Developing Gut Complications. J Pediatr Gastroenterol Nutr. 2018 May;66(5):755-759. doi: 10.1097/MPG.0000000000001804.

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• Ozdel D, Sari HY. Effects of the prone position and kangaroo care on gastric residual volume, vital signs and comfort in preterm infants. Jpn J Nurs Sci. 2020 Jan;17(1):e12287. doi: 10.1111/jjns.12287. Epub 2019 Oct 23.

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• Patel AK, Lazar DA, Burrin DG, Smith EO, Magliaro TJ, Stark AR, Brandt ML, Zamora IJ, Sheikh F, Akinkuotu AC, Olutoye OO. Abdominal near-infrared spectroscopy measurements are lower in preterm infants at risk for necrotizing enterocolitis. Pediatr Crit Care Med. 2014 Oct;15(8):735-41. doi: 10.1097/PCC.0000000000000211.

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• Seager E, Longley C, Aladangady N, Banerjee J. Measurement of gut oxygenation in the neonatal population using near-infrared spectroscopy: a clinical tool? Arch Dis Child Fetal Neonatal Ed. 2020 Jan;105(1):76-86. doi: 10.1136/archdischild-2018-316750. Epub 2019 Jun 1.

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• Tran NN, Kumar SR, Hodge FS, Macey PM. Cerebral Autoregulation in Neonates With and Without Congenital Heart Disease. Am J Crit Care. 2018 Sep;27(5):410-416. doi: 10.4037/ajcc2018672.

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• Ziehenberger E, Urlesberger B, Binder-Heschl C, Schwaberger B, Baik-Schneditz N, Pichler G. Near-infrared spectroscopy monitoring during immediate transition after birth: time to obtain cerebral tissue oxygenation. J Clin Monit Comput. 2018 Jun;32(3):465-469. doi: 10.1007/s10877-017-0052-9. Epub 2017 Aug 19.

  PMID: 28823017 BACKGROUND

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction

Model Details: Breastfed preterm neonates to be included in the study will be placed in 3 positions in a randomized crossover design. The order of the 3 positions that will be given to the babies in the research group will be determined by drawing lots and 3 intervention groups will be formed. Preterm newborns in each intervention group will be followed for two hours after feeding in all three positions: semi-elevated supine position, prone position, and right lateral position. Positions will be given to babies, taking into account the order of positions in each group. All positions will be applied once to each baby. Groups and position rankings according to the result of the draw: 1. st group: Prone, right lateral and semi-raised supine position 2. nd group: Semi-raised supine, prone and right lateral position 3. rd group: Right lateral, semi-raised supine and prone position 48 preterm newborns in the study group will be randomly assigned to these 3 intervention groups.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: June 4, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)