Standardized oral care using human milk for premature infants in the NICU
Frequent Standardized Oral Care Using Human Milk to Prevent Oral Dysbiosis and Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
This study is trying to see if giving regular oral care using human milk can help very low birth weight babies in the NICU stay healthier and avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 1 Hour to 3 Days |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06000761 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of frequent standardized oral care on very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU). It aims to address the lack of established guidelines for oral care in this vulnerable population, which is at high risk for complications such as ventilator-associated pneumonia and bronchopulmonary dysplasia. The study will follow 168 VLBW infants for four weeks after birth to assess the effects of this intervention on their health outcomes. By developing evidence-based guidelines, the research seeks to improve the overall care and health of these infants.
Who should consider this trial
Good fit: Ideal candidates for this study are mothers aged 18 or older with infants born at or before 30 weeks gestation and weighing 1500 grams or less.
Not a fit: Patients with congenital anomalies of the face, lungs, or gastrointestinal system, or those not expected to survive more than 7 days after delivery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes and reduced complications for premature infants in NICUs.
How similar studies have performed: While similar approaches have shown success in critically ill adults, this specific intervention for VLBW infants is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * Mother ≥18 years of age * ≤ 30 weeks gestation * Born weighing ≤ 1500 grams Exclusion: * Congenital anomalies of the face, lungs, or gastrointestinal system * Not expected to live \> 7 days following delivery.
Where this trial is running
Gainesville, Florida
- Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Leslie Parker, PHD — University of Florida
- Study coordinator: Leslie A Parker, PhD, APRN
- Email: parkela@ufl.edu
- Phone: 352-273-6384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.