The Developmental Effects of NICU Positioning

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Roberta Pineda, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT01628510

First received: June 19, 2012

Last updated: June 22, 2012

Last verified: June 2012

History of Changes

Purpose

The purpose of this study is to investigate the developmental effects of two different types of positioning used with premature infants in the neonatal intensive care unit.

Condition	Intervention	Phase
Preterm Infants	Device: Traditional Positioning Device: Dandle Roo/Dandle Wrap	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Clinical Trial Investigating the Developmental Effects of Two Different Methods of Neonatal Positioning in the NICU

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

NICU Network Neurobehavioral Scale (NNNS) [ Time Frame: Near term equivalent; prior to NICU discharge ] [ Designated as safety issue: No ]
The NNNS will be used to assess neurobehavioral outcome near term equivalent (between 35 weeks and 41 weeks postmenstrual age). This tool consists of eliciting neonatal reflexes and observing behavior. From the assessment, 13 summary scores are determined for habituation, orientation, self regulation, tolerance of handling, hypertonia, hyotonia, asymmetry, lethargy, excitability, sub-optimal reflexes, arousal, and stress.

Secondary Outcome Measures:

The Bayley Scales of Infant Development-3rd Edition (BSID-III) [ Time Frame: 6 months, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]
The BSID-III is the gold standard for assessing developmental outcome in childhood. Domain scores for language, motor and cognition will be determined.

Enrollment:	100
Study Start Date:	January 2011
Estimated Study Completion Date:	December 2014
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Traditional NICU Positioning Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.	Device: Traditional Positioning Traditional positioning methods are used with the infant throughout the NICU hospitalization. Other Name: Snuggly, Bendy Bumper
Experimental: Dandle Roo/Dandle Wrap The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.	Device: Dandle Roo/Dandle Wrap Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held. Other Name: Dandle Roo; Dandle Wrap

Arms

Assigned Interventions

Active Comparator: Traditional NICU Positioning

Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.

Device: Traditional Positioning

Traditional positioning methods are used with the infant throughout the NICU hospitalization.

Other Name: Snuggly, Bendy Bumper

Experimental: Dandle Roo/Dandle Wrap

The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.

Device: Dandle Roo/Dandle Wrap

Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held.

Other Name: Dandle Roo; Dandle Wrap

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 7 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:Inclusion:

Premature infants born at or before 32 weeks gestation

Exclusion Criteria:

Congenital Anomaly

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628510

Locations

United States, Missouri
St Louis Children's Hospital
St Louis, Missouri, United States, 63110
Barnes Special Care Nursery
St Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Roberta G Pineda, PhD OTR/L

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Roberta Pineda, Research Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01628510 History of Changes
Other Study ID Numbers:	201111170
Study First Received:	June 19, 2012
Last Updated:	June 22, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

preterm

ClinicalTrials.gov processed this record on June 18, 2013

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