Late-Onset Neonatal Sepsis Clinical Trial
Official title:
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no treatment control.
Purpose and Specific Aims The purpose is to determine the effect of twice daily topical coconut oil application on late onset sepsis in neonates admitted to the Neonatal Intensive Care Units of Indira Gandhi Institute of Child Health, Cloudnine Hospital at Old Airport Road, and Cloudnine Hospital at Jayanagar in Bangalore, India. The aim is to determine the effect of topical coconut oil application on: - The incidence of neonatal late onset culture positive sepsis - Neonatal skin integrity versus a no treatment control using standard skin evaluation methods - Biomarkers of neonatal innate immune function - Temperature instability, weight gain, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, chronic lung disease, and mortality. The investigators hypothesize that twice daily topical coconut oil application will reduce the incidence of late onset sepsis (LOS) in premature and full-term infants versus the current standard of care, i.e., no treatment. The oil treatment will increase the neonatal skin barrier integrity measured by validated clinical and instrumental methods. Skin surface biomarkers of innate immune function collected from coconut oil treated skin will indicate less inflammation (lower proinflammatory cytokine levels) than in untreated control skin. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05530330 -
Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
|
||
| Not yet recruiting |
NCT06199102 -
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
|
N/A | |
| Recruiting |
NCT04717037 -
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)
|
Phase 2/Phase 3 | |
| Completed |
NCT03299751 -
Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates
|
N/A | |
| Not yet recruiting |
NCT06118801 -
The Effect of Probiotics Added to the Mother's Diet on Preterm Babies
|
N/A | |
| Completed |
NCT03822104 -
Bovine Colostrum as a Human Milk Fortifier for Preterm Infants
|
N/A | |
| Completed |
NCT04424667 -
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
|
N/A | |
| Recruiting |
NCT05981079 -
Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
|
Phase 4 | |
| Recruiting |
NCT05991648 -
Effect of Kangaroo Care on Heart Rate Variability in Late-onset Neonatal Sepsis
|
N/A | |
| Completed |
NCT03085277 -
Bovine Colostrum for Preterm Newborns
|
N/A | |
| Recruiting |
NCT05347238 -
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
|
||
| Completed |
NCT04792918 -
Characterization of Intestinal Microbiota Stability in Preterm Born Neonates
|
||
| Recruiting |
NCT03997266 -
NICU Antibiotics and Outcomes Trial
|
Phase 4 | |
| Completed |
NCT03633500 -
Effectiveness of Oral Immunotherapy Among Preterm Babies
|
N/A |