Intestinal DiseasePhase 2LRNCT01236833
Lactated Ringer's Solution in Neonates With Feeding Intolerance
A Phase 2 study testing Lactated Ringer's Solution in people with Intestinal Disease and Feeding Disorder Neonatal, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 2 days and older
- Conditions the study is for
- Intestinal Disease, Feeding Disorder Neonatal
- What is being tested?
- Lactated Ringer's Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2010to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McGill University Health Center
Montreal, Quebec, H3H 2R9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: Enteral Administration of Lactated Ringer's Solution in Neonates With Feeding Intolerance, a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Lactated Ringer's Solution
- Keywords
- Lactated Ringer's Solution, Isotonic Solution, Intestinal Disease, Feeding Intolerance, Necrotizing Enterocolitis, Newborn, Premature Infant
- Medical subject headings
- Intestinal Diseases, Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer's SolutionDrug
Also called Lactated Ringer's
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
| Study group | Role | What they receive |
|---|---|---|
| Fasting | No intervention | Not described |
| Lactated Ringer's Solution | Active comparator | Not described Receives: Drug: Lactated Ringer's Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (7)
Number of days to reach 130 ml/kg milk feeding
Measured: variable
Number of days to discontinue IV access
Measured: variable
Growth (weight, height, head circumference), increase % after 14 days and between study entry and discharge home
Measured: variable
Length of hospitalization
Measured: variable
Necrotizing enterocolitis
Measured: during the 14 day-study period and hospitalization
Electrolytes, bilirubin, serum urea nitrogen, creatinine and liver enzymes
Measured: 14 days
Infections
Measured: until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Gaelle Sadani, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreLouis Beaumier, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236833
- Sponsor's protocol ID
- 09-225-PED
- Acronym
- LR
- Status last verified
- Aug 2011
- First submitted
- 8 Nov 2010
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17180128
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Administration of Lactated Ringer's Solution in Neonates With Feeding Intolerance, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01236833
- Acronym / sponsor ID
- LR / 09-225-PED
- Conditions
- Intestinal Disease, Feeding Disorder Neonatal
- Keywords
- Lactated Ringer's Solution, Isotonic Solution, Intestinal Disease, Feeding Intolerance, Necrotizing Enterocolitis, Newborn, Premature Infant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | No intervention | – |
| Lactated Ringer's Solution | Active comparator | Drug: Lactated Ringer's Solution |
Who may qualify
- Ages
- 2 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Documented informed consent for participation in the study
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactated Ringer's SolutionAlso: Lactated Ringer's2.5 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 | Drug | Lactated Ringer's Solution |
Primary outcome
Average of the daily enteral caloric intake (in calories/kg/day) received over the 14 days after study entry
Time frame: 14 days
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.
7 secondary outcomes
Number of days to reach 130 ml/kg milk feeding
Time frame: variable
Number of days to discontinue IV access
Time frame: variable
Growth (weight, height, head circumference), increase % after 14 days and between study entry and discharge home
Time frame: variable
Length of hospitalization
Time frame: variable
Necrotizing enterocolitis
Time frame: during the 14 day-study period and hospitalization
Electrolytes, bilirubin, serum urea nitrogen, creatinine and liver enzymes
Time frame: 14 days
Infections
Time frame: until discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
- Background: PubMed 17180128Barney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaelle Sadani, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Louis Beaumier, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactated Ringer's Solution in people with Intestinal Disease and Feeding Disorder Neonatal, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average of the daily enteral caloric intake (in calories/kg/day) received over the 14 days after study entry (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2011.