Effectiveness of Positioning in Preterm Neonates

NCT04251260 | Unknown

• 1 other identifier: UPatras2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: When babies are born prematurely, they are deprived of their usual space limits (uterus walls). This along with the action of gravity to which they are exposed after birth, makes the neonates have a low muscle tone, acquire a posture of extension, being more irritable and having difficulties with their alertness-sleep cycle. There are few studies that have assessed the effectiveness of positioning of premature neonates. However, none of these studies has focused on exploring the effects of positioning on the patterns of movement and gross motor function of the pre-term neonates. Aim: The aim of this study is to investigate the effects of positioning on the patterns of movement, gross motor development and physiological clinical outcomes of pre-term neonates. Methods: A sample of pre-term neonates of ≤ 32 weeks of gestation from the Neonatal Intensive Care Unit (NICU) of the General University Hospital of Patras will be randomly assigned to two groups. The intervention group will receive positioning with Snuggle up (Philips, USA), while the control group will receive usual care. Outcomes will be assessed with the general movements of Prechtl and the Denver II scale at baseline and at term-age of each neonate. Physiological outcomes will be also assessed such as heart rate, respiratory rate, weight gained from baseline to term-age, days to achieve full oral feeding, days on the ventilator, days on oxygen, and duration of stay in the NICU. Basic characteristics of the neonates will be obtained from their medical record, i.e. weeks of gestation at birth, gender, type of birth (normal or Caesarian), weight at birth, and Αpgar score and will be used to compare the 2 groups for similarities at the baseline of the trial.

Conditions

Premature Baby 26 to 32 Weeks; Preterm Birth

Keywords

preterm; positioning; snuggle up; general movements

Outcome Measures

Primary Outcomes (2)

• Change from baseline General movements at 40 weeks

  General Movements (GM's) of Prechtl using 5-minute video observations of each neonate for the assessment

  From baseline to 40 weeks

• Change from 40 weeks Denver II Developmental Screening Test at 4 months of corrected age

  The purpose of the test is to identify young children with developmental problems

  From 40 weeks to 4 months of corrected age

Secondary Outcomes (6)

• Change from baseline Beats per minute (heart rate ) at 40 weeks

  From baseline to 40 weeks

• Change from baseline Breaths per minute (respiratory rate) at 40 weeks

  From baseline to 40 weeks

• Change from baseline Weight at 40 weeks

  From baseline to 40 weeks

• Days till full feeding

  Up to 40 weeks

• Days the neonate needed oxygen

  Up to 40 weeks

Study Arms (2)

Positioning in flexion

EXPERIMENTAL

Intervention: Positioning of body in flexion and aligment towards midline with Snuggle up (Philips, USA)

Other: Positioning in flexion

Control group

NO INTERVENTION

No intervention

Interventions

Positioning in flexion OTHER

The intervention group will be positioned in flexion (i.e. lower limbs in flexion, hand in midline) with an aid, the Snuggle up (Philips, USA). With positioning, the neonates bottom is tucked down in the snuggle up pocket, legs are aligned and gently flexed and hands towards midline and near the face. Positioning will be demonstrated to the nursing staff of the Neonatal Intensive Care Unit (NICU). The intervention group will receive positioning during day and night throughout the intervention period.

Positioning in flexion

Eligibility Criteria

• Age: 24 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Νeonates of 33 weeks of gestation or less

You may not qualify if:

• Νeonates
• with congenital deformities or genetic anomalies
• with neurological deficits detected at 1st week post-natal
• of multiple birth (triplets and over) or breech deliveries

Sponsors & Collaborators

• University of Patras: lead
• University Hospital of Patras: collaborator

Study Sites (1)

University of Patras

Pátrai, 265 04, Greece

Location

Related Publications (8)

• Toso BR, Viera CS, Valter JM, Delatore S, Barreto GM. Validation of newborn positioning protocol in Intensive Care Unit. Rev Bras Enferm. 2015 Nov-Dec;68(6):1147-53. doi: 10.1590/0034-7167.2015680621i. English, Portuguese.

  PMID: 26676439 BACKGROUND

• Zarem C, Crapnell T, Tiltges L, Madlinger L, Reynolds L, Lukas K, Pineda R. Neonatal nurses' and therapists' perceptions of positioning for preterm infants in the neonatal intensive care unit. Neonatal Netw. 2013 Mar-Apr;32(2):110-6. doi: 10.1891/0730-0832.32.2.110.

  PMID: 23477978 BACKGROUND

• Bernhardt I, Marbacher M, Hilfiker R, Radlinger L. Inter- and intra-observer agreement of Prechtl's method on the qualitative assessment of general movements in preterm, term and young infants. Early Hum Dev. 2011 Sep;87(9):633-9. doi: 10.1016/j.earlhumdev.2011.04.017. Epub 2011 May 26.

  PMID: 21616611 BACKGROUND

• Sathish Y, Edward Lewis L, Angelitta Noronha J, George A, Snayak B, S Pai M, et al. Clinical Outcomes of Snuggle up Position Using Positioning Aids for Preterm (27-32 Weeks) Infants. Iranian Journal of Neonatology. 2017

  BACKGROUND

• Pereira FL, Nogueira de Goes Fdos S, Fonseca LM, Scochi CG, Castral TC, Leite AM. [Handling of preterm infants in a neonatal intensive care unit]. Rev Esc Enferm USP. 2013 Dec;47(6):1272-8. doi: 10.1590/S0080-623420130000600003. Portuguese.

  PMID: 24626374 BACKGROUND

• Madlinger-Lewis L, Reynolds L, Zarem C, Crapnell T, Inder T, Pineda R. The effects of alternative positioning on preterm infants in the neonatal intensive care unit: a randomized clinical trial. Res Dev Disabil. 2014 Feb;35(2):490-7. doi: 10.1016/j.ridd.2013.11.019. Epub 2013 Dec 25.

  PMID: 24374602 BACKGROUND

• Einspieler C, Marschik PB, Pansy J, Scheuchenegger A, Krieber M, Yang H, Kornacka MK, Rowinska E, Soloveichick M, Bos AF. The general movement optimality score: a detailed assessment of general movements during preterm and term age. Dev Med Child Neurol. 2016 Apr;58(4):361-8. doi: 10.1111/dmcn.12923. Epub 2015 Sep 14.

  PMID: 26365130 BACKGROUND

• Yeh KK, Liu WY, Wong AM, Chung CY, Lien R, Chuang YF. Intra-observer reliability of Prechtl's method for the qualitative assessment of general movements in Taiwanese infants. J Phys Ther Sci. 2016 May;28(5):1588-94. doi: 10.1589/jpts.28.1588. Epub 2016 May 31.

  PMID: 27313378 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Theofani Bania

  University of Patras, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the principal investigator who is not an assessor will know the allocation of the neonates to the 2 groups. The assessors will be blind to the allocation of the neonates.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Physiotherapy

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 31, 2020
• Study Start: September 20, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

GR (1)