Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive

Status Recruiting

Clinical Trial Summary

Premature infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 168 VLBW infants for 4 weeks following birth.

Clinical Trial Description

Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. Premature VLBW infants are highly susceptible to costly, life threatening and potentially preventable morbidities, such as ventilator associated pneumonia (VAP), bronchopulmonary dysplasia (BPD; oxygen requirement at 28 days of life) and need for prolonged respiratory support which require additional treatments, increase cost of care, and can lead to chronic illness, re-hospitalization, and developmental delay. A dearth of information exists regarding oral care in VLBW infants, and no such guidelines exist for infants admitted to the neonatal intensive care unit (NICU) which may negatively affect their health. Thus, research regarding the effect of frequent, standardized oral care on the health of VLBW infants is essential to develop guidelines thus potentially improving the health of this vulnerable population. If successful, this research could change practice in NICUs across the nation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06000761
Study type	Interventional
Source	University of Florida
Contact	Leslie A Parker, PhD, APRN
Phone	352-273-6384
Email	parkela@ufl.edu
Status	Recruiting
Phase	N/A
Start date	November 23, 2023
Completion date	December 20, 2026

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04506619` - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed	`NCT04936477` - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants	N/A
Recruiting	`NCT05285345` - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Terminated	`NCT02524249` - Early Versus Late Caffeine for ELBW Newborns	N/A
Completed	`NCT02249143` - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants	N/A
Active, not recruiting	`NCT01632475` - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed	`NCT01460576` - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt	N/A
Completed	`NCT00419588` - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Unknown status	`NCT00254176` - Cysteine Supplementation in Critically Ill Neonates	Phase 2/Phase 3
Completed	`NCT00208039` - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates	N/A
Completed	`NCT00319956` - Trial II of Lung Protection With Azithromycin in the Preterm Infant	Phase 2
Completed	`NCT00006401` - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants	Phase 3
Terminated	`NCT05030012` - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants	N/A
Completed	`NCT00006058` - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns	N/A
Completed	`NCT00005376` - Premature Birth and Its Sequelae in Women	N/A
Completed	`NCT00011362` - Dexamethasone Therapy in VLBW Infants at Risk of CLD	Phase 3
Completed	`NCT00004805` - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death	N/A
Completed	`NCT05152316` - The Baby Lung Study
Recruiting	`NCT04821453` - NAVA vs. CMV Crossover in Severe BPD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms