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

Primary Purpose

Intestinal Disease, Feeding Disorder Neonatal

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Lactated Ringer's Solution
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Disease focused on measuring Lactated Ringer's Solution, Isotonic Solution, Intestinal Disease, Feeding Intolerance, Necrotizing Enterocolitis, Newborn, Premature Infant

Eligibility Criteria

2 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McGill University Health Center
  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Fasting

Lactated Ringer's Solution

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of days to reach 130 ml/kg milk feeding
Number of days to discontinue IV access
Growth (weight, height, head circumference), increase % after 14 days and between study entry and discharge home
Length of hospitalization
Necrotizing enterocolitis
Electrolytes, bilirubin, serum urea nitrogen, creatinine and liver enzymes
Infections

Full Information

First Posted
November 8, 2010
Last Updated
August 2, 2011
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01236833
Brief Title
Lactated Ringer's Solution in Neonates With Feeding Intolerance
Acronym
LR
Official Title
Enteral Administration of Lactated Ringer's Solution in Neonates With Feeding Intolerance, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Disease, Feeding Disorder Neonatal
Keywords
Lactated Ringer's Solution, Isotonic Solution, Intestinal Disease, Feeding Intolerance, Necrotizing Enterocolitis, Newborn, Premature Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fasting
Arm Type
No Intervention
Arm Title
Lactated Ringer's Solution
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer's Solution
Other Intervention Name(s)
Lactated Ringer's
Intervention Description
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
Primary Outcome Measure Information:
Title
Average of the daily enteral caloric intake (in calories/kg/day) received over the 14 days after study entry
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Number of days to reach 130 ml/kg milk feeding
Time Frame
variable
Title
Number of days to discontinue IV access
Time Frame
variable
Title
Growth (weight, height, head circumference), increase % after 14 days and between study entry and discharge home
Time Frame
variable
Title
Length of hospitalization
Time Frame
variable
Title
Necrotizing enterocolitis
Time Frame
during the 14 day-study period and hospitalization
Title
Electrolytes, bilirubin, serum urea nitrogen, creatinine and liver enzymes
Time Frame
14 days
Title
Infections
Time Frame
until discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaelle Sadani, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Louis Beaumier, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17180128
Citation
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.
Results Reference
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Lactated Ringer's Solution in Neonates With Feeding Intolerance

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