Microbial Colonization Clinical Trial
Official title:
Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
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 dybiosis (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 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05414994 -
Assessment of the Ocular Microbiome in Health and Disease
|
||
| Completed |
NCT04769882 -
Er:YAG Laser Effects on Microbial Population in Conservative Dentistry
|
N/A | |
| Completed |
NCT04766528 -
Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity
|
N/A | |
| Completed |
NCT03720314 -
Microbiota Profiling in IBS
|
||
| Completed |
NCT04122612 -
Shaping Microbiome in the First 1,000 Days of Life
|
||
| Not yet recruiting |
NCT05405634 -
Microbiota in Chronic Anal Fissure and Its Association With Prognosis
|
||
| Not yet recruiting |
NCT04895774 -
Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
|
||
| Recruiting |
NCT05992688 -
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
|
N/A | |
| Recruiting |
NCT05502380 -
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
|
Phase 3 | |
| Completed |
NCT05175833 -
Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19
|
Phase 2 | |
| Recruiting |
NCT04836910 -
Microbiome and Polycystic Ovaries
|
||
| Recruiting |
NCT05603650 -
Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
|
N/A | |
| Completed |
NCT04991818 -
MSC - OneBiome UX Pilot Study
|
N/A | |
| Completed |
NCT05575050 -
Impact of Teeth Brushing in Ventilated COVID-19 Patients.
|
N/A | |
| Completed |
NCT04374955 -
The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content
|
N/A | |
| Recruiting |
NCT04140747 -
Transfer of Strictly Anaerobe Microbes From Mother to Child
|
||
| Recruiting |
NCT04111471 -
The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients
|
N/A | |
| Suspended |
NCT03220282 -
The Milk, Growth and Microbiota Study
|
N/A | |
| Completed |
NCT03422562 -
Probiotics and Intestinal Microbiome in Preterm Infants
|
Phase 3 | |
| Recruiting |
NCT05695196 -
Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant
|
Phase 1 |