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Clinical Trials/NCT04251260
NCT04251260Enrolling By InvitationNot Applicable

Effectiveness of Positioning on the Movement and Clinical Physiological Outcomes of Preterm Neonates

University of Patras1 site in 1 country50 target enrollmentStarted: September 20, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
50
Locations
1
Primary Endpoint
Change from baseline General movements at 40 weeks

Study Overview

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.

Detailed Description

Study Protocol

Introduction:

The NICU provides a sensory overload through excessive handling, noisy environment, neglected cry, prolonged sleep state and social interactions of the newborns with the professionals. All these make difficult the internal organization of the preterm neonate (Pereira et al, 2013). Also, when babies are born prematurely, their muscles have not yet acquired the appropriate tone which is normally low compared to the muscle tone of full-term neonates. With the deprivation of their usual space limits (uterus walls) and the action of gravity to which the neonates are exposed after birth, the preterm neonates acquire a posture of extension, which is contrary to the flexion they usually adopt in the uterus. This extension position does not help the flexion of their limbs and makes the hand-mouth activities and meeting the middle line difficult. Further, the deprivation of the physical rhythms of the neonates' usual space creates insecurity, irritability, increased extensive motor activity and difficulties with respiration and alertness-sleep cycle (Toso et al, 2015; Zarem et al, 2013).

There is a randomized controlled trial (RCT) that investigated the effectiveness of positioning on the general condition and ability to be fed of 100 neonates (≤ 32 weeks of gestation). This study compared a positioning using the Dandle Roo (DandleLion Medical) with traditional or other positioning (e.g. rolls of sheets, snuggle up) (Madlinger-Lewis et al, 2013). At term-age, a significant difference was found between the two groups, favoring the Dandle Roo positioning, in the movements symmetry as assessed with the NICU Network Neurobehavioral Scale (mean difference: 0.90, 95% confidence intervals: 0.05 to 1.75). No other significant differences were observed at rest of outcomes. Another RCT including 56 preterm neonates (27-32 weeks of gestation) explored the effects of positioning with the Snuggle up and Bendy Pumpers (Philips, USA) in comparison to traditional positioning (rolls of soft fabric). The results showed a significant difference between the two groups, favoring the intervention group, in respiratory rate, oxygen saturation, score of cardiovascular stability, and weight gain (p<0.5) (Sathish et al, 2017).

However, none of these previous studies has investigated any differences in the patterns of movement of the pre-term neonates after a positioning intervention. For example, no study has assessed the gross motor function of the pre-term neonates using the general movements of Prechtl after a positioning intervention, although this assessment is considered important for the prognosis of the motor development and ability for independence of these children (Einspieler et al, 2016). No previous study has also assessed the effect of positioning in the long-term neuro-developmental progress of pre-term children with scales such as the Denver II scale, which scale is also important for the prognosis of the development of the neonate.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
24 Weeks to 33 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Νeonates of 33 weeks of gestation or less

Exclusion Criteria

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

Arms & Interventions

Control group

No Intervention

No intervention

Positioning in flexion

Experimental

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

Intervention: Positioning in flexion (Other)

Outcomes

Primary Outcomes

Change from baseline General movements at 40 weeks

Time Frame: From baseline to 40 weeks

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

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

Time Frame: From 40 weeks to 4 months of corrected age

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

Secondary Outcomes

  • 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)
  • Duration of stay in the NICU(Up to 40 weeks)
  • Change from baseline Beats per minute (heart rate ) at 40 weeks(From baseline to 40 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Theofani Bania

Assistant Professor, Department of Physiotherapy

University of Patras

Study Sites (1)

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