NCT04715451

Swaddling to Improve Neurodevelopment for Preterm Babies

A Novel Swaddling Method To Improve Developmental Care for Preterm Babies

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 24 Weeks – 37 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Preterm Birth
• Neurodevelopmental Disorders

Interventions

Type	Name	Description
OTHER	Novel Swaddle	A novel swaddling method.

Timeline

• Start date: 2025-04-21
• Primary completion: 2025-04-21
• Completion: 2025-04-21
• First posted: 2021-01-20
• Last updated: 2025-04-24