Lactated Ringer's Solution in Neonates With Feeding Intolerance (LR)
|ClinicalTrials.gov Identifier: NCT01236833|
Recruitment Status : Unknown
Verified August 2011 by McGill University Health Center.
Recruitment status was: Active, not recruiting
First Posted : November 9, 2010
Last Update Posted : August 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Disease Feeding Disorder Neonatal||Drug: Lactated Ringer's Solution||Phase 2|
Feeding intolerance is a common problem in premature infants in the Neonatal Intensive Care Unit. Definition is clinical and based on abdominal distension, abdominal tenderness, emesis, change in gastric residuals, presence of blood in stool, and apnea with bradycardia.
Feeding intolerance is associated with serious complications: necrotizing enterocolitis, longer hospitalization and prolonged intravenous nutrition complications (e.g. sepsis, liver damage). Therefore, the investigators aim to achieve adequate enteral nutrition as soon as possible.
Because LR is a an amniotic fluid-like solution, it may improve gastro-intestinal function and avoid fasting, as well as its multiple problems (e.g. intestinal atrophy and decreased intestinal motility). LR was chosen as the test solution because of experience documenting its safe use in comparable groups: in newborn resuscitation parenterally, in amnioinfusion, and in bowel irrigation. Moreover, LR is similar in electrolytes composition to the experimental solution used in previous studies by Barney et al in neonates.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enteral Administration of Lactated Ringer's Solution in Neonates With Feeding Intolerance, a Randomized Controlled Trial|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||September 2012|
|No Intervention: Fasting|
|Active Comparator: Lactated Ringer's Solution||
Drug: Lactated Ringer's Solution
2.5 ml per kg every 3 hours, via nasogastric tube, orogastric tube or orally, until the infant reaches 80 ml/kg/day of milk feeding or for a maximum of 14 days
Other Name: Lactated Ringer's
- Average of the daily enteral caloric intake (in calories/kg/day) received over the 14 days after study entry [ Time Frame: 14 days ]To measure enteral caloric intake, the volume of milk feeding, for each patient will be recorded daily and for 14 days. Unfortified milk and fortified milk are calculated as containing respectively 0.67 Cal/ml and 0.81 Cal/ml.
- Number of days to reach 130 ml/kg milk feeding [ Time Frame: variable ]
- Number of days to discontinue IV access [ Time Frame: variable ]
- Growth (weight, height, head circumference), increase % after 14 days and between study entry and discharge home [ Time Frame: variable ]
- Length of hospitalization [ Time Frame: variable ]
- Necrotizing enterocolitis [ Time Frame: during the 14 day-study period and hospitalization ]
- Electrolytes, bilirubin, serum urea nitrogen, creatinine and liver enzymes [ Time Frame: 14 days ]
- Infections [ Time Frame: until discharge ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236833
|McGill University Health Center|
|Montreal, Quebec, Canada, H3H 2R9|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Principal Investigator:||Gaelle Sadani, MD||McGill University Health Center|
|Principal Investigator:||Louis Beaumier, MD||McGill University Health Center|