Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01628510 |
| Other study ID # |
201111170 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 19, 2012 |
| Last updated |
January 29, 2018 |
| Start date |
January 2011 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
January 2018 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
Infants born prematurely have a high risk of developmental impairment. Subsequently, preterm
infants are often seen by therapy services in the neonatal intensive care unit and are often
recommended for early intervention services at discharge. One of the earliest interventions
for preterm infants in the Neonatal Intensive Care Unit (NICU) is positioning, as altered
positioning can have a significant impact on later function.
Preterm infants have a positioning disadvantage from early on in their development. The final
trimester of pregnancy promotes the flexed position, when the infant is crowded by the
uterine environment and experiences rapid brain growth, mediating flexion and midline
orientation. When infants are born too soon, they miss the in utero flexion positioning. They
lack the central nervous system maturity to enable flexion and do not have the tone and
strength for movement against gravity. In addition, preterm infants are confronted with
altered sensory experiences, resulting from static, extended positioning and environmental
factors associated with life and medical interventions outside the womb. Therefore, early
transition to the extrauterine environment is a challenge for premature infants, as they face
overwhelming sensory stimuli that their bodies are not yet prepared to process.
It has been demonstrated that the positioning of the preterm infant differs from that of a
full term infant. The tightly flexed positioning of a full term newborn is called
physiological flexion. It involves symmetrical flexion of the extremities, shoulder
protraction, and posterior pelvic tilt.
Physiological flexion has developmental importance. This positioning enables infants to
remain motorically and physiologically organized and facilitates self-soothing and
self-regulation behaviors, such as sucking and hand to mouth contact. The flexed position
provides the infant with a sense of containment and security, which mimics the intrauterine
environment. In addition, physiological flexion is associated with greater extremity contact
with the trunk, which imitates the womb and gives infants sensory feedback.
The benefits of early physiological flexion can have long term benefits on development. Many
neonatal reflexes, such as upper and lower extremity recoil, palmar and plantar grasp, and
pull to sit are mediated by flexion response. These early flexion responses form the
foundation for later movement acquisition. Physiological flexion also promotes later
development of normal balance and posture. Ideal posture supports the development of head
control, sitting, crawling, walking, transferring from one position to another, and
manipulating objects. Due to missing the third trimester, preterm infants are at risk for
assuming suboptimal positions, thus missing the early benefits of physiological flexion.
In utero, fetuses experience attenuated stimuli. Therefore, sensory experiences outside the
womb are overwhelming for infants born prematurely (3). As a result, preterm infants are
easily stressed, particularly when they are not properly positioned.
Stress can produce severe consequences in the preterm infant including respiratory problems
and intraventricular hemorrhage. Infants in an unsupported position may have frantic
movements and startles in response to stress, and therefore have difficulty achieving the
deep sleep state necessary for growth and brain development. This can lead to extended
hospital stays. Optimal positioning enables premature infants to better cope with stressors
and bring their hand to face and mouth for self-soothing.
Positioning aids in the past have aimed at promoting containment and increasing flexion.
However, the ability to promote flexion while enabling infant movement remained problematic.
The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the
neurodevelopment of the preterm infant. 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.
Despite the current evidence on effective positioning interventions for preterm infants, a
recent meta-analysis on developmental care cited a need for more research of specific
interventions, such as positioning, on short-term and long-term clinical outcomes. No studies
to date have examined the effects of the new Dandle Roo and Dandle Wrap on clinical and
neurobehavioral outcomes in preterm infants. Therefore, we propose a randomized controlled
trial of the new Dandle Roo/ Dandle Wrap, postulating that infants positioned in the Dandle
Roo/Dandle Wrap will experience beneficial effects.
Objectives:
Hypothesis - Preterm infants positioned in the Dandle Roo and Dandle Wrap will experience
better neurodevelopmental outcome, less brain injury and need for respiratory support, and
shorter hospital stays than infants positioned in traditional NICU positioning aids.
Specific Aim - To conduct a randomized controlled trial on the effects of the Dandle
Roo/Dandle Wrap versus traditional NICU positioning administered from birth through discharge
from the NICU on neurodevelopmental outcome, brain injury, need for respiratory support, and
length of stay in infants born less than 32 weeks postmenstrual age (PMA).
Subjects: A power analysis revealed that 86 infants were needed to detect a difference in
neurobehavioral outcome following a positioning intervention. To account for attrition, 100
infants will be recruited.
Inclusion Criteria - This is a prospective cohort with premature infants who are born at 32
weeks or less PMA. This cohort will be hospitalized in the NICU at St. Louis Children's
Hospital or the Barnes Special Care Nursery in St. Louis, Missouri and will be recruited
within 72 hours of birth.
Exclusion Criteria - Infants with a known or suspected congenital anomaly at birth and
infants who are moribund with severe sepsis or respiratory distress defined as physiologic
instability requiring >80% FiO2 for 6 hours and/or more than 2 ionotropic drugs (excluding
hydrocortisone), or in the attending or recruiting physicians' opinion the infant is likely
to expire within 24 hours or would not tolerate any handling for the protocol
Randomization - As soon after birth as possible, but no later than 1 week after admission,
consecutive new admissions meeting the inclusion criteria will be recruited for the study.
Upon parent's signing the informed consent, an infant will be randomly assigned to either
Dandle Roo/Dandle Wrap positioning or to traditional NICU positioning for the entire length
of stay.
The positioning protocol assigned to each study infant would be clearly posted at each
infant's bedside. Members of the research team would routinely check in to ensure that
infants in the treatment arm were positioned correctly in the Dandle Roo/Dandle Wrap and to
answer any questions. In addition, a log sheet would be placed at the infant's bedspace for
each nursing shift. Here nurses would be instructed to identify if the infant was positioned
in the assigned positioning aid and would be able to identify reasoning if the positioning
was not implemented during a specific shift.
Positioning protocols would be utilized during times when the infant is resting in the crib,
isolette, or open warmer. However, the infant would be taken out of the positioning aids
periodically for hands on care, for bedside evaluation, or to enable closer observation
during acute episodes. In addition, parents could take the infant out of the positioning for
holding and interaction.
Clinical Data Collection:
For all infants enrolled, routine clinical information from the infant's medical record would
be accessed.
In addition, each infant would undergo neurobehavioral testing by a member of the research
team during the hospitalization. One trained and certified evaluator will conduct all
neurobehavioral tests on all study infants. Testing would be conducted between 35 weeks
gestation and 41 weeks gestation. Neurobehavioral assessment that will be used is the
Neonatal NICU Network Scales (NNNS). Scores range from 0-13 in the following subscales:
habituation, attention, handling, arousal, regulation, quality of movement, reflexes,
asymmetrical responses, hypertonicity, hypotonicity, stress/abstinence signs. High scores are
optimal on the following subscales: habituation, attention, regulation, and quality of
movement. Low scores are optimal on the following subscales: handling, arousal, reflexes,
asymmetrical responses, hypertonicity, hypotonicity and stress/abstinence signs.
Developmental testing would only be conducted on infants who were medically stable and able
to tolerate the exam. Video taping of each neurobehavioral assessment will be performed and
stored anonymously. Videotapes will be conducted to enable close observation of the infant
during the evaluation process with later scoring of the test from the videotape. In addition,
testing from the ongoing developmental follow up clinic (Washington University Neonatal
Developmental Follow-Up Clinic) would be accessed for outcomes at 6 months, 1 year, 2 years,
and 3 years, when available.
Dissemination of results:
The findings from this research will be:
- Published in peer review scientific medical literature
- Presented at local and international conferences
- Disseminated, at the end of the study period, to all parents whose infants were enrolled
in the study who expressed interest in the study outcome.
Potential Benefits:
Ideal neonatal positioning may improve neurodevelopment and decrease brain injury and need
for respiratory support, with subsequent better developmental outcome. Optimizing positioning
and facilitating more optimal in utero positioning during this time period could result in
shorter hospital stays, decreasing expenditure of healthcare dollars. Early neurobehavioral
testing, which is part of the study protocol, can enable parents to better understand the
strengths and weaknesses exhibited by their infant to enable early therapeutic interventions.
Benefits to society include a better understanding of effective positioning in the NICU as
well as a possible understanding about how early positioning can be critical for later
function.
A member of the research team will conduct a comprehensive developmental test on the infant
during the NICU stay. Parents will be informed of test results prior to or at NICU discharge.
The WUNDER research group will be continuously reviewing the data results as they return and
report any adverse effects monthly to the St. Louis Children's Hospital Neonatal Intensive
Care Unit Joint Practice Committee. The biostatistician will also independently review data
results and report any significant adverse effects monthly to the WUNDER research group and
the Joint Practice Committee. All serious adverse events will be reported to the IRB: a)
death - immediately; b) life-threatening within 7 calendar days; c) all other significant
adverse events (SAEs) within 15 calendar days using the Electronic SAE System.
Data Analysis:
Data will be analyzed using linear and logistic regression models by a biostatistician. Data
will be reviewed throughout the duration of the study. All data will be maintained in the
strictest confidence and will only be available to members of the research team. It will be
held in secure format in password-protected computer records. Hard copy and the records will
be identified only by study number and stored in a locked file cabinet. A log of study number
and identifying data will be kept by the site PI in a separate locked file cabinet. All file
cabinets containing data are inside a locked office in a corridor accessible only with badge
access.
