Lactated Ringer's Solution in Neonates With Feeding Intolerance

NCT ID: NCT01236833

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-09-30

Brief 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.

Detailed 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.

Conditions

Intestinal Disease; Feeding Disorder Neonatal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fasting

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lactated Ringer's Solution

Group Type: ACTIVE_COMPARATOR

Lactated Ringer's Solution

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Lactated Ringer's

Eligibility Criteria

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

• Minimum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

The Research Institute of the McGill University Health Centre

Principal Investigators

Gaelle Sadani, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Louis Beaumier, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

McGill University Health Center

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 17180128 (View on PubMed)

Other Identifiers

09-225-PED

Identifier Type: -

Identifier Source: org_study_id