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The objective of this study is determining if enteral administration of Lactated Ringer's solution (LR) in preterm infants with feeding intolerance enables for faster advancement of milk feeding than fasting.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting | No Intervention | ||
| Lactated Ringer's Solution | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactated Ringer's Solution | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average of the daily enteral caloric intake (in calories/kg/day) received over the 14 days after study entry | 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days to reach 130 ml/kg milk feeding | variable | |
| Number of days to discontinue IV access | variable | |
| Growth (weight, height, head circumference), increase % after 14 days and between study entry and discharge home |
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Inclusion Criteria:
Birth gestational age (GA) between 25 and 32 weeks
Corrected gestational age less than 34 weeks
Enteral feeding tolerated at a minimum of 10 ml/kg/day for a minimum of 48 hours
Severe feeding intolerance, defined as a minimum of one or more of the following signs leading to withholding of milk feedings on two evaluations over 12 to 24 hours:
Documented informed consent for participation in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaelle Sadani, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Louis Beaumier, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Center | Montreal | Quebec | H3H 2R9 | Canada | ||
| Jewish General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17180128 | Background | Barney CK, Lambert DK, Alder SC, Scoffield SH, Schmutz N, Christensen RD. Treating feeding intolerance with an enteral solution patterned after human amniotic fluid: a randomized, controlled, masked trial. J Perinatol. 2007 Jan;27(1):28-31. doi: 10.1038/sj.jp.7211609. |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D020345 | Enterocolitis, Necrotizing |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| variable |
| Length of hospitalization | variable |
| Necrotizing enterocolitis | during the 14 day-study period and hospitalization |
| Electrolytes, bilirubin, serum urea nitrogen, creatinine and liver enzymes | 14 days |
| Infections | until discharge |
| Montreal |
| Quebec |
| H3T 1E2 |
| Canada |
| D007752 |
| Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |