Lactated Ringer's Solution in Neonates With Feeding Intolerance (LR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by McGill University Health Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01236833
First received: November 8, 2010
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Intestinal Disease
Feeding Disorder Neonatal
Drug: Lactated Ringer's Solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enteral Administration of Lactated Ringer's Solution in Neonates With Feeding Intolerance, a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Average of the daily enteral caloric intake (in calories/kg/day) received over the 14 days after study entry [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of days to reach 130 ml/kg milk feeding [ Time Frame: variable ] [ Designated as safety issue: No ]
  • Number of days to discontinue IV access [ Time Frame: variable ] [ Designated as safety issue: Yes ]
  • Growth (weight, height, head circumference), increase % after 14 days and between study entry and discharge home [ Time Frame: variable ] [ Designated as safety issue: No ]
  • Length of hospitalization [ Time Frame: variable ] [ Designated as safety issue: No ]
  • Necrotizing enterocolitis [ Time Frame: during the 14 day-study period and hospitalization ] [ Designated as safety issue: Yes ]
  • Electrolytes, bilirubin, serum urea nitrogen, creatinine and liver enzymes [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Infections [ Time Frame: until discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236833

Locations
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3H 2R9
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Gaelle Sadani, MD McGill University Health Center
Principal Investigator: Louis Beaumier, MD McGill University Health Center
  More Information

Publications:
Responsible Party: Louis Beaumier, The Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01236833     History of Changes
Other Study ID Numbers: 09-225-PED
Study First Received: November 8, 2010
Last Updated: August 2, 2011
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
Lactated Ringer's Solution
Isotonic Solution
Intestinal Disease
Feeding Intolerance
Necrotizing Enterocolitis
Newborn
Premature Infant

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014