Lactated Ringer's Solution in Neonates With Feeding Intolerance

Intestinal Disease Clinical Trial

— LR  

Official title:

Enteral Administration of Lactated Ringer's Solution in Neonates With Feeding Intolerance, a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01236833
• Other study ID #: 09-225-PED
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 8, 2010
• Last updated: August 2, 2011
• Start date: November 2010
• Est. completion date: September 2012

Study information

• Verified date: August 2011
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

1. Significant increased abdominal girth, as evaluated by the treatment team, with abdominal tenderness

2. Visible enlarged bowel loops with abdominal tenderness

3. Recurrent emesis leading to withhold feeds

4. Gastric residuals in excess of one feeding, recurrent or with growing abdominal girth

5. Visible blood in stools without anal etiology

• Documented informed consent for participation in the study

Exclusion Criteria:

• Infants who already reached full enteral feeds for 72 hours, in fact a minimum of 130 ml/kg/day enteral feeds without parenteral supplementation.

• Small for gestational age (SGA) (weight at or less than the 3rd percentile on the Fenton growth chart)

• NEC (Bell's stage II or higher, radiologic evidence of NEC, pneumatosis intestinalis or free intraperitoneal air)or history of NEC

• Gastric or intestinal occlusion (no transit, absent bowel sounds, incessant vomiting, bile stained vomiting or air fluid levels)

• Major congenital malformation

• Septic infants requiring therapeutic antibiotics or antimycotics (infants only on prophylactic antibiotics or antimycotics should not be excluded).

• Patients judged as being too ill to enroll in this study, as defined by a requirement for mechanical ventilation with >50% FIO2

• Patent Ductus Arteriosus requiring ibuprofen, indomethacin or ligature, until one week after the end of treatment

• Intraventricular Haemorrhage grade 3 or 4

• Hypernatremia = 150 mmol/L

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Feeding Disorder Neonatal
• Intestinal Disease
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of days to reach 130 ml/kg milk feeding		variable	No
Secondary	Number of days to discontinue IV access		variable	Yes
Secondary	Growth (weight, height, head circumference), increase % after 14 days and between study entry and discharge home		variable	No
Secondary	Length of hospitalization		variable	No
Secondary	Necrotizing enterocolitis		during the 14 day-study period and hospitalization	Yes
Secondary	Electrolytes, bilirubin, serum urea nitrogen, creatinine and liver enzymes		14 days	Yes
Secondary	Infections		until discharge	Yes