Trial Outcomes & Findings for The Developmental Effects of NICU Positioning (NCT NCT01628510)

Results Overview

The NNNS wasl 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 were determined for each of the following constructs: habituation (1-9), orientation (1-9), self regulation (1-9), tolerance of handling (0-1), hypertonia (0-10), hypotonia (0-10), asymmetry (0-16), lethargy (0-15), excitability (0-15), sub-optimal reflexes (0-15), arousal (1-9), quality of movement (1-9) and stress (0-1). Each summary score is analyzed for associations with subsequent developmental outcome. A higher score in each category indicates more of that construct. Specifically, for the summary score of asymmetry (the significant finding in this study), higher scores equal more asymmetry.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

35 to 41 weeks (term equivalent); prior to NICU discharge

Results posted on

2018-02-27

Participant Flow

One hundred infants were enrolled from January 2011 through November 2011. Four infants withdrew, and four infants died. Ninety two participants were discharged from the NICU.

All eligible infants were recruited. Those whose parents signed informed consent were randomized to either traditional positioning or Dandle Roo positioning.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	51	49
Overall Study COMPLETED	48	44
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	0	4
Overall Study Death	3	1

Baseline Characteristics

The Developmental Effects of NICU Positioning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Traditional NICU Positioning n=44 Participants 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. Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization.	Dandle Roo/Dandle Wrap n=48 Participants 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. 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.	Total n=92 Participants Total of all reporting groups
Age, Continuous	29.4 weeks STANDARD_DEVIATION 2.8 • n=5 Participants	28 weeks STANDARD_DEVIATION 2.5 • n=7 Participants	28.7 weeks STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 35 to 41 weeks (term equivalent); prior to NICU discharge

The NNNS wasl 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 were determined for each of the following constructs: habituation (1-9), orientation (1-9), self regulation (1-9), tolerance of handling (0-1), hypertonia (0-10), hypotonia (0-10), asymmetry (0-16), lethargy (0-15), excitability (0-15), sub-optimal reflexes (0-15), arousal (1-9), quality of movement (1-9) and stress (0-1). Each summary score is analyzed for associations with subsequent developmental outcome. A higher score in each category indicates more of that construct. Specifically, for the summary score of asymmetry (the significant finding in this study), higher scores equal more asymmetry.

Outcome measures

Outcome measures
Measure	Traditional NICU Positioning n=44 Participants 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. Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization.	Dandle Roo/Dandle Wrap n=48 Participants 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. 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.
NICU Network Neurobehavioral Scale (NNNS)	3.1 Asymmetry Score (units on a scale) Standard Deviation 2.1	2.56 Asymmetry Score (units on a scale) Standard Deviation 1.9

SECONDARY outcome

Timeframe: 1 year, 2 years

Population: 23 total participants completed Bayley Scales follow-up testing at 1 year; 7 total participants completed Bayley Scales follow-up testing at 2 years.

The BSID-III is the gold standard for assessing developmental outcome in childhood. Subscale composite scores for language, motor and cognition will be determined. * Language --Scale Range (higher values represent a better outcome) * Minimum Score: 40 * Maximum Score: 160 * Motor --Scale Range (higher values represent a better outcome) * Minimum Score: 40 * Maximum Score: 160 * Cognition --Scale Range (higher values represent a better outcome) * Minimum Score: 40 * Maximum Score: 160

Outcome measures

Outcome measures
Measure	Traditional NICU Positioning n=8 Participants 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. Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization.	Dandle Roo/Dandle Wrap n=15 Participants 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. 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.
The Bayley Scales of Infant Development-3rd Edition (BSID-III) Cognitive - 1 year	90 units on a scale Standard Deviation 22.99	105.71 units on a scale Standard Deviation 16.97
The Bayley Scales of Infant Development-3rd Edition (BSID-III) Language - 1 year	85.57 units on a scale Standard Deviation 18.93	94.73 units on a scale Standard Deviation 19.18
The Bayley Scales of Infant Development-3rd Edition (BSID-III) Motor - 1 year	82.88 units on a scale Standard Deviation 25.27	96.50 units on a scale Standard Deviation 11.02
The Bayley Scales of Infant Development-3rd Edition (BSID-III) Cognitive - 2 year	75 units on a scale Standard Deviation 8.66	95 units on a scale Standard Deviation 5
The Bayley Scales of Infant Development-3rd Edition (BSID-III) Language - 2 year	77.33 units on a scale Standard Deviation 8.5	91.33 units on a scale Standard Deviation 8.5
The Bayley Scales of Infant Development-3rd Edition (BSID-III) Motor - 2 year	79 units on a scale Standard Deviation 13.75	91 units on a scale Standard Deviation 12

Adverse Events

Dandle Roo/Dandle Wrap

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional NICU Positioning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberta Pineda

Washington University

Phone: 314-286-1304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place