Prematurity Clinical Trial
Official title:
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Hypothesis to be Tested:
Since the first description of intravenous alimentation over half a century ago, parenteral
nutrition (PN) has become a common nutritional intervention for conditions characterized by
inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal
Pseudoobstruction, Microvillus Inclusion Disease, Crohn's disease, multi-organ failure and
prematurity. Parenteral Nutrition-Associated Liver Disease (PNALD) encompasses a spectrum of
disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may
progress to liver cirrhosis and even failure.
There is a direct correlation between duration of parenteral nutrition and development of
cholestasis in infants. There is evidence in animals and humans that cycling of parental
nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces
cholestasis. There is also data that premature infants with gestational age (GA) < 32 weeks
and birth weight <1500g, as well as infants with congenital anomalies of the
gastrointestinal tract, are among those at highest risk of developing Parenteral
Nutrition-Associated Cholestasis (PNAC).
We therefore hypothesize that infants with gestational age (GA) <32 weeks and birth weight
(BW) between <1500g, or with congenital anomaly of the gastrointestinal tract regardless of
GA or BW, receiving PN over a period of 20 hours will have a decrease severity of PNAC,
demonstrated by a lower peak direct bilirubin, compared to a similar control population
receiving standard 24 hour infusion.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03670732 -
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
|
N/A | |
Completed |
NCT05322161 -
Yoga in the NICU for Parents Study
|
N/A | |
Recruiting |
NCT04542096 -
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
|
||
Recruiting |
NCT04911452 -
Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants
|
N/A | |
Recruiting |
NCT02901652 -
NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT02148965 -
Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
|
N/A | |
Terminated |
NCT02032511 -
Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)
|
N/A | |
Completed |
NCT02273843 -
A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis
|
Phase 1 | |
Completed |
NCT01721629 -
Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants
|
N/A | |
Terminated |
NCT01819532 -
Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks
|
N/A | |
Completed |
NCT00951860 -
Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort
|
N/A | |
Completed |
NCT01478711 -
Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
|
N/A | |
Completed |
NCT01523769 -
Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
|
N/A | |
Completed |
NCT00749008 -
Study of Generalized Movements for Early Prediction of Cerebral Palsy
|
N/A | |
Completed |
NCT00787124 -
Transfusions and Nitric Oxide Level in Preterm Infants
|
||
Terminated |
NCT00486395 -
Will CPAP Reduce Length Of Respiratory Support In Premature Infants?
|
Phase 3 | |
Completed |
NCT00527956 -
Facilitation and Barriers to Breastfeeding in the NICU
|
N/A | |
Terminated |
NCT01208493 -
Dietary Protein in the Very-low-birth-weight Infant
|
N/A | |
Completed |
NCT03372590 -
NEO Rehab for Infants at Risk of Cerebral Palsy
|
N/A | |
Completed |
NCT00033917 -
Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
|
Phase 3 |