RECRUITING

Baby ABS (Abdominal Binder Study)

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Conditions

PrematurePremature LungsVentilator Lung; NewbornRectus AbdominisbCPAPCPAPNAVA CPAP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary outcome of this study is to determine if the use of the FDA-approved DandleLion NeoBellyBand increases the thickness of the rectus abdominis muscle in premature babies receiving continuous positive pressure ventilation, leading to infants reaching full oral feedings at an earlier corrected gestational age.

Official Title

Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support

Quick Facts

Study Start:2025-09-22
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07049900

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.

Ages Eligible for Study:26 Weeks to 31 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Premature viable neonates with corrected gestational age of 26-31 weeks
  2. * Anticipated to require non-invasive continuous positive pressure ventilation including bCPAP, CPAP, and NAVA CPAP for a minimum of 2 weeks either on their first trial of CPAP or after extubation.
  1. * Outside of gestational age at birth
  2. * Umbilical lines
  3. * Genetic condition or neuromuscular anomaly
  4. * Known abdominal anomaly
  5. * Non-viable neonates and neonates with uncertain viability who are not anticipated to be able to survive with standard NICU care.
  6. * Surgical intervention on the abdominal wall, such as gastroschisis or history of surgical NEC
  7. * Compromised skin integrity of abdominal wall
  8. * Any condition in the opinion of the investigator that would risk the data integrity or collection of the study

Contacts and Locations

Study Contact

Andrea Charara, MD
CONTACT
(612) 626-0644
chara061@umn.edu

Principal Investigator

Sarah Ramel, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Sarah Ramel, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

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 Registration Dates

Study Start Date2025-09-22
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2025-09-22
Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

  • bCPAP
  • CPAP
  • NAVA CPAP

Additional Relevant MeSH Terms

  • Premature
  • Premature Lungs
  • Ventilator Lung; Newborn
  • Rectus Abdominis