Clinical trial NCT04715451: Swaddling to Improve Neurodevelopment for Preterm Babies
Official title: A Novel Swaddling Method To Improve Developmental Care for Preterm Babies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Preterm Birth
Neurodevelopmental Disorders
Keywords: Preterm
Brain
Neurodevelopment
Swaddling
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: The Thomas Wilson Sanitarium for Children of Baltimore City
First posted: 2021-01-20
Enrollment: 0
Sex: ALL
Minimum age (years): 24
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* Born very preterm (\<32 weeks postmenstrual age (PMA))
* At least 12 hours and less than 2 months old
* Expected to survive \> 3 days
* No congenital anomaly or genetic disorder with expected survival less than term equivalent
* No malformations requiring surgery within 1 month of life
* Central intravenous lines removed
* Approval of the primary neonatologist, ideally not a study team member, to approach family for consent
* Appropriate parent or guardian to provide informed consent

Exclusion Criteria:

* Life expectancy \< 3 days
* Severe congenital anomaly or genetic disorder with life expectancy \<40 weeks PMA
* Seizures
* Need for seizure medication
* Hypertension for age requiring medication
* Severe hematologic crisis such as disseminated intravascular coagulation
* Hydrops fetalis
* Clinical concern or diagnosis of toxoplasmosis, cytomegalovirus rubella or syphilis infection
* Clinical concern or diagnosis of severe acute respiratory distress syndrome coronavirus 2 (SARS CoV-2) or coronavirus disease (COVID-19)
* Central intravenous access and reliance on parenteral nutrition \>50%
* Respiratory support greater than nasal canulae or nasal continuous positive airway pressure (CPAP) (i.e. ventilator dependent)
* Active infection, including need for antibiotics greater than 5 days (i.e. confirmed infection)
* Complex congenital heart disease
* Known chromosomal abnormalities
* Clinical or echocardiographic signs of symptomatic pulmonary hypertension
* Profound perinatal hypoxia-ischemia
* Receiving treatment for pain control
* Sustained tachypnea \>80 breaths/minute
* Need for volume expansion or administration of inotropes
* No one available or willing to provide consent

Primary outcomes:
measure: Change in Sleep-Wake Cycling Maturity as assessed by amplitude integrated EEG (aEEG) readings
timeFrame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
measure: Change in length of time spent in sleep
timeFrame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
measure: Change in the number of awakenings in a 3 hour time period
timeFrame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
measure: Change in voltage as assessed by aEEG) readings
timeFrame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
measure: Change in ratio of active sleep and quiet sleep as assessed by amplitude integrated EEG (aEEG) readings
timeFrame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
measure: Change in Sleep-Wake Cycling Continuity as assessed by amplitude integrated EEG (aEEG) readings
timeFrame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Secondary outcomes:
measure: Behavioral Maturity as assessed by the NNNS
timeFrame: 37 weeks postmenstrual age
measure: Change in General Movements as assessed by the GMA
timeFrame: 32 weeks postmenstrual age and 37 weeks postmenstrual age
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Lauren Jantzie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kitase Y, Sato Y, Takahashi H, Shimizu M, Ishikawa C, Yamamoto H, Hayakawa M. A new type of swaddling clothing improved development of preterm infants in neonatal intensive care units. Early Hum Dev. 2017 Sep;112:25-28. doi: 10.1016/j.earlhumdev.2017.06.005. Epub 2017 Jul 1.