Effectiveness of Positioning in Preterm Neonates
|ClinicalTrials.gov Identifier: NCT04251260|
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2020
Last Update Posted : March 25, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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.|
|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|
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
- 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
- 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
- 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
- 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
- Days till full feeding [ Time Frame: Up to 40 weeks ]This information will be collected from each neonate's file
- Days the neonate needed oxygen [ Time Frame: Up to 40 weeks ]This information will be collected from neonates file
- Duration of stay in the NICU [ Time Frame: Up to 40 weeks ]This information will be collected from neonates file
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251260
|University of Patras|
|Patra, Greece, 265 04|
|Principal Investigator:||Theofani Bania||University of Patras, Greece|