Preterm BirthNCT04715451
Swaddling to Improve Neurodevelopment for Preterm Babies
A study testing Novel Swaddle in people with Preterm Birth and Neurodevelopmental Disorders, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 37 weeks
- Conditions the study is for
- Preterm Birth, Neurodevelopmental Disorders
- What is being tested?
- Novel Swaddle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2025to 21 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- Novel Swaddle
- Keywords
- Preterm, Brain, Neurodevelopment, Swaddling
- Medical subject headings
- Premature Birth, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel SwaddleOther
A novel swaddling method.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Novel Swaddle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Secondary outcomes (2)
Behavioral Maturity as assessed by the NNNS
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.
Measured: 37 weeks postmenstrual age
Change in General Movements as assessed by the GMA
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.
Measured: 32 weeks postmenstrual age and 37 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start21 Apr 2025
- Primary completion21 Apr 2025
- Study completion21 Apr 2025
Why it stopped: Study withdrawn due to staffing/funding concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The Thomas Wilson Sanitarium for Children of Baltimore City
- Responsible party
- Sponsor
- Investigators
- Lauren Jantzie, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715451
- Sponsor's protocol ID
- IRB00261157
- Status last verified
- Apr 2025
- First submitted
- 14 Jan 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28675824
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Swaddling Method To Improve Developmental Care for Preterm Babies
- ClinicalTrials.gov ID
- NCT04715451
- Acronym / sponsor ID
- IRB00261157
- Conditions
- Preterm Birth, Neurodevelopmental Disorders
- Keywords
- Preterm, Brain, Neurodevelopment, Swaddling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to staffing/funding concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The Thomas Wilson Sanitarium for Children of Baltimore City
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Novel SwaddleThe 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. |
Who may qualify
- Ages
- 24 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel SwaddleA novel swaddling method. | Other | Novel Swaddle |
Primary outcome
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.
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.
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.
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).
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).
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.
2 secondary outcomes
Behavioral Maturity as assessed by the NNNS
Time frame: 37 weeks postmenstrual age
Change in General Movements as assessed by the GMA
Time frame: 32 weeks postmenstrual age and 37 weeks postmenstrual age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 28675824Kitase 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Jantzie, PhD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Novel Swaddle in people with Preterm Birth and Neurodevelopmental Disorders, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.