An interventional study of Novel Swaddle in Preterm Birth and Neurodevelopmental Disorders, sponsored by Johns Hopkins University. Withdrawn. Open to participants aged 24 Weeks to 37 Weeks. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Supportive care
The investigators will test a new medical grade swaddling system for optimal and more appropriate positioning for preterm infants. This is a trial focused on sleep state, state regulation and long-term neurodevelopment. The central hypothesis is that this novel swaddling method will promote sleep and an optimal sleep-wake cycle, while also improving the neurodevelopment of preterm infants. It is proposed that adequate positioning and secondary feedback of natural movement of arms and legs stimulates and fosters normal brain development.
Throughout pregnancy, the fetus is encouraged to develop by maintaining proper flexed posture in the uterus and freely moving its arms and legs against the flexible boundaries of the womb. However, when born too early, preterm infants lose the natural boundaries of the womb that support this flexor positioning and movement support. In addition preterm infants undergo stress because of essential treatments in neonatal intensive care units and exposure to the extrauterine environment. To support the development of preterm infants, cotton wraps are often used to maintain appropriate body positioning. Swaddling helps maintain continuous and adequate body positioning which aids and provides a stable sleep environment and encourages muscle tone. However, traditional swaddling is challenging in preterm infants and preterm infants frequently become unswaddled. It is fraught with difficulties related to the neonatal care and monitoring preterm infants receive due to the prematurity. In addition, this stiff material does not provide the same sensory experience as the flexible boundaries of the womb. In response to this challenge, The Investigators developed a new medical grade swaddling system for optimal and more appropriate positioning and natural movement. Here, The Investigators outline a trial focused on sleep state, state regulation and long-term neurodevelopment. The central hypothesis is that this novel swaddling method will promote sleep and an optimal sleep-wake cycle, while also improving the neurodevelopment of preterm infants. It is proposed that adequate positioning and secondary feedback of natural movement of arms and legs stimulates and fosters normal brain development. The Investigators will clinically evaluate sleep at the level of amplitude-integrated electroencephalograph (aEEG) activity and perform the Prechtl's Assessment of General Movements (GMA) to assess spontaneous writhing and fidgety movements, which predicts the future neurodevelopment of preterm babies. The Investigators will also perform the Neonatal Intensive Care Unit (NICU) Network Neurobehavioural Scale (NNNS) as a standardized assessment of neurological integrity and organization. The goal is to provide early intervention to improve development in preterm infants.
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Exclusion Criteria:
The management of the non-intervention group is with a cotton swaddle that is standard of care. It represents a conventional standard management method using a swaddle made of cotton.
The Novel Swaddle is made of fabric consisting of 85% nylon and 15% polyurethane. This fabric provides heat retention, is hygroscopic and stretches in both longitudinal and transverse directions, thus more accurately replicating the intrauterine environment. The novel material is sewed into a bag shape.
Other: Novel Swaddle
A novel swaddling method.
Change in Sleep-Wake Cycling Maturity as assessed by amplitude integrated EEG (aEEG) readings
Using aEEG, the Investigators will assess the presence or absence of mature sleep-wake cycling as defined as regular rhythmic sinusoidal variations of amplitude with a cycle greater than or equal to 20 minutes. Tracings with a cycling pattern that does not fit into a mature sleep-wake cycle for the majority of the tracing will be classified as intermediate.
Time frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Change in length of time spent in sleep
Using aEEG, the Investigators will assess the change in length of time (in minutes) spent in sleep.
Time frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Change in the number of awakenings in a 3 hour time period
Using aEEG, the Investigators will assess the change in number of awakenings in a 3 hour time period.
Time frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Change in voltage as assessed by aEEG) readings
Using aEEG, the Investigators will assess the change in voltage (measured in microvolts).
Time frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Change in ratio of active sleep and quiet sleep as assessed by amplitude integrated EEG (aEEG) readings
Using aEEG The Investigators will assess the time spent in active sleep (irregular and low in amplitude) and quiet sleep (regular and high in amplitude).
Time frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Change in Sleep-Wake Cycling Continuity as assessed by amplitude integrated EEG (aEEG) readings
Using aEEG The Investigators will examine the background activity on recordings to assess the presence or absence of isoelectric periods along with amplitude fluctuations. Tracings will be classified as continuous, discontinuous and borderline.
Time frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Behavioral Maturity as assessed by the NNNS
The NICU Network Neurobehavioural Scale (NNNS) is a standardized clinical assessment tool used to assess neurological integrity and organization in a single, structured clinical exam. Summary scores are created for neurobehavioral domains including: habituation, attention, handling, quality of movement, self-regulation, non optimal reflexes, asymmetrical reflexes, stress/abstinence, arousal, hypertonicity, excitability, and lethargy. 13 summary scores will be generated.
Time frame: 37 weeks postmenstrual age
Change in General Movements as assessed by the GMA
Prechtl's General Movement Assessment (GMA) is a clinical assessment tool that classifies writhing movements in preterm infants. Specifically, classification of writhing movements will be made as cramped synchronous, poor repertoire with cramped synchronicity, or poor repertoire.
Time frame: 32 weeks postmenstrual age and 37 weeks postmenstrual age
No study locations are listed for this record.
Plan to share: No
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