Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04715451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2021-01-14
Brief Title:
Swaddling to Improve Neurodevelopment for Preterm Babies
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
A Novel Swaddling Method To Improve Developmental Care for Preterm Babies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Prechtls 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None