Swaddling to Improve Neurodevelopment for Preterm Babies

NCT04715451 | Withdrawn DMC

• 1 other identifier: IRB00261157
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preterm Birth; Neurodevelopmental Disorders

Keywords

Preterm; Brain; Neurodevelopment; Swaddling

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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).

  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).

  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.

  32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age

Secondary Outcomes (2)

• Behavioral Maturity as assessed by the NNNS

  37 weeks postmenstrual age

• Change in General Movements as assessed by the GMA

  32 weeks postmenstrual age and 37 weeks postmenstrual age

Study Arms (2)

Conventional Swaddle

NO INTERVENTION

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.

Novel Swaddle

EXPERIMENTAL

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

Interventions

Novel Swaddle OTHER

A novel swaddling method.

Novel Swaddle

Eligibility Criteria

• Age: 24 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• The Thomas Wilson Sanitarium for Children of Baltimore City: collaborator

Related Publications (1)

• 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.

  PMID: 28675824 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Study Officials

• Lauren Jantzie, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: April 21, 2025
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share