Swaddling to Improve Neurodevelopment for Preterm Babies

April 21, 2025 updated by: Johns Hopkins University

A Novel Swaddling Method To Improve Developmental Care for Preterm Babies

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 months to 8 months (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: 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.
Other: Novel Swaddle
A novel swaddling method.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Sleep-Wake Cycling Maturity as assessed by amplitude integrated EEG (aEEG) readings
Time Frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
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
Time Frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
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
Time Frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
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
Time Frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
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
Time Frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
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
Time Frame: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavioral Maturity as assessed by the NNNS
Time Frame: 37 weeks postmenstrual age
The NICU Network Neurobehavioural Scale (NNNS) is a standardized clinical assessment tool used to assess neurological integrity and organization in a single, structured clinical exam. Summary scores are created for neurobehavioral domains including: habituation, attention, handling, quality of movement, self-regulation, non optimal reflexes, asymmetrical reflexes, stress/abstinence, arousal, hypertonicity, excitability, and lethargy. 13 summary scores will be generated.
37 weeks postmenstrual age
Change in General Movements as assessed by the GMA
Time Frame: 32 weeks postmenstrual age and 37 weeks postmenstrual age
Prechtl's General Movement Assessment (GMA) is a clinical assessment tool that classifies writhing movements in preterm infants. Specifically, classification of writhing movements will be made as cramped synchronous, poor repertoire with cramped synchronicity, or poor repertoire.
32 weeks postmenstrual age and 37 weeks postmenstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Thomas Wilson Sanitarium for Children of Baltimore City

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lauren Jantzie, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00261157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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