Status:
WITHDRAWN
Swaddling to Improve Neurodevelopment for Preterm Babies
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
The Thomas Wilson Sanitarium for Children of Baltimore City
Conditions:
Preterm Birth
Neurodevelopmental Disorders
Eligibility:
All Genders
24-37 years
Phase:
NA
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-ter...
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, wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04715451
Start Date
April 21 2025
End Date
April 21 2025
Last Update
April 24 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.