Lactated Ringer's Solution in Neonates With Feeding Intolerance

NCT01236833 | Unknown Phase 2 DMC

• 1 other identifier: 09-225-PED
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Intestinal Disease; Feeding Disorder Neonatal

Keywords

Lactated Ringer's Solution; Isotonic Solution; Intestinal Disease; Feeding Intolerance; Necrotizing Enterocolitis; Newborn; Premature Infant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

  variable

• Length of hospitalization

  variable

• Necrotizing enterocolitis

  during the 14 day-study period and hospitalization

Study Arms (2)

Fasting

NO INTERVENTION

Lactated Ringer's Solution

ACTIVE COMPARATOR

Drug: Lactated Ringer's Solution

Interventions

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

Also known as: Lactated Ringer's

Lactated Ringer's Solution

Eligibility Criteria

• Age: 2 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Significant increased abdominal girth, as evaluated by the treatment team, with abdominal tenderness
• Visible enlarged bowel loops with abdominal tenderness
• Recurrent emesis leading to withhold feeds
• Gastric residuals in excess of one feeding, recurrent or with growing abdominal girth
• Visible blood in stools without anal etiology
• Documented informed consent for participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (2)

McGill University Health Center

Montreal, Quebec, H3H 2R9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related 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. doi: 10.1038/sj.jp.7211609.

  PMID: 17180128 BACKGROUND

MeSH Terms

Conditions

Intestinal Diseases; Enterocolitis, Necrotizing; Premature Birth

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Enterocolitis; Gastroenteritis; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 4, 2011

Record last verified: 2011-08

Locations

CA (2)