Swaddling to Improve Neurodevelopment for Preterm Babies

NCT ID: NCT04715451

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2025-04-21

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.

Conditions

Preterm Birth; Neurodevelopmental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Conventional Swaddle

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Novel Swaddle

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.

Group Type: EXPERIMENTAL

Novel Swaddle

Intervention Type: OTHER

A novel swaddling method.

Interventions

Novel Swaddle

A novel swaddling method.

Intervention Type: OTHER

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

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Thomas Wilson Sanitarium for Children of Baltimore City

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Jantzie, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

References

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.

Reference Type: BACKGROUND

PMID: 28675824 (View on PubMed)

Other Identifiers

IRB00261157

Identifier Type: -

Identifier Source: org_study_id