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Effectiveness of Positioning in Preterm Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251260
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Theofani Bania, University of Patras

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.


Condition or disease Intervention/treatment Phase
Premature Baby 26 to 32 Weeks Preterm Birth Other: Positioning in flexion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Effectiveness of Positioning on the Movement and Clinical Physiological Outcomes of Preterm Neonates
Estimated Study Start Date : June 20, 2020
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Arm Intervention/treatment
Experimental: Positioning in flexion
Intervention: Positioning of body in flexion and aligment towards midline with Snuggle up (Philips, USA)
Other: Positioning in flexion

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.


No Intervention: Control group
No intervention



Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Change from baseline Beats per minute (heart rate ) at 40 weeks [ Time Frame: From baseline to 40 weeks ]
    The heart rate will be measured with a monitor connected to the neonate

  2. Change from baseline Breaths per minute (respiratory rate) at 40 weeks [ Time Frame: From baseline to 40 weeks ]
    The respiratory rate will be measured with a monitor connected to the neonate

  3. Change from baseline Weight at 40 weeks [ Time Frame: From baseline to 40 weeks ]
    Weight gained during the intervention period measured with the NICU scales

  4. Days till full feeding [ Time Frame: Up to 40 weeks ]
    This information will be collected from each neonate's file

  5. Days the neonate needed oxygen [ Time Frame: Up to 40 weeks ]
    This information will be collected from neonates file

  6. Duration of stay in the NICU [ Time Frame: Up to 40 weeks ]
    This information will be collected from neonates file



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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Νeonates of 32 weeks of gestation or less

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251260


Locations
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Greece
University of Patras
Patra, Greece, 265 04
Sponsors and Collaborators
University of Patras
Investigators
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Principal Investigator: Theofani Bania University of Patras, Greece
Publications:
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

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Responsible Party: Theofani Bania, Assistant Professor, Department of Physiotherapy, University of Patras
ClinicalTrials.gov Identifier: NCT04251260    
Other Study ID Numbers: UPatras2019
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theofani Bania, University of Patras:
preterm
positioning
snuggle up
general movements
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications