Premature Birth of NewbornPhase 2NCT01093638
Oral Formulation of Insulin for Preterm Infants
A Phase 2 study testing Oral Formulation of Insulin in people with Premature Birth of Newborn, run by Elgan Pharma Ltd. at 1 site in Israel.
Trial summary
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol. Read more about this study
- Who is it for?
- Ages 26 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Birth of Newborn
- What is being tested?
- Oral Formulation of Insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Jan 2016
- 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 26 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Pre-term infants 26-33 weeks gestation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants.
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
Read the detailed description
The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.
- Conditions
- Premature Birth of Newborn
- Being tested
- Oral Formulation of Insulin, Placebo
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Formulation of InsulinBiological
Oral formulation of insulin fed concomitantly with infant formula
PlaceboBiological
Oral formulation of placebo fed concomitantly with infant formula
| Study group | Role | What they receive |
|---|---|---|
| Oral Formulation of Insulin | Experimental | Oral formulation of insulin fed concomitantly with premature infant formula Receives: Biological: Oral Formulation of Insulin |
| Oral Formulation of Placebo | Placebo comparator | Oral formulation of placebo fed concomitantly with premature infant formula Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days to achieve complete enteral feeding
Measured: Up to 28 days or discharge and at 3 months of age
Secondary outcomes (4)
Number of gastric residual > 2 ml/kg
Measured: Up to 28 days or discharge, at 3 months of age
Number of gastric residual > 50% of previous feeding
Measured: Up to 28 days or discharge and at 3 months of age
Number of days to discharge
Measured: Up to 28 days or discharge and at 3 months of age
Weight gain
Measured: Up to 28 days or discharge and at 3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Birth of NewbornStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elgan Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naim Shehadeh, Prof., Study director, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093638
- Sponsor's protocol ID
- CTILYAB004409LND10LaniadoH
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2010
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants.
- ClinicalTrials.gov ID
- NCT01093638
- Acronym / sponsor ID
- CTILYAB004409LND10LaniadoH
- Conditions
- Premature Birth of Newborn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Elgan Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Mar 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 study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
Detailed description
The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Formulation of Insulin | Experimental | Biological: Oral Formulation of InsulinOral formulation of insulin fed concomitantly with premature infant formula |
| Oral Formulation of Placebo | Placebo comparator | Biological: PlaceboOral formulation of placebo fed concomitantly with premature infant formula |
Who may qualify
- Ages
- 26 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Pre-term infants 26-33 weeks gestation.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oral Formulation of InsulinOral formulation of insulin fed concomitantly with infant formula | Biological | Oral Formulation of Insulin |
| PlaceboOral formulation of placebo fed concomitantly with infant formula | Biological | Oral Formulation of Placebo |
Primary outcome
Number of days to achieve complete enteral feeding
Time frame: Up to 28 days or discharge and at 3 months of age
4 secondary outcomes
Number of gastric residual > 2 ml/kg
Time frame: Up to 28 days or discharge, at 3 months of age
Number of gastric residual > 50% of previous feeding
Time frame: Up to 28 days or discharge and at 3 months of age
Number of days to discharge
Time frame: Up to 28 days or discharge and at 3 months of age
Weight gain
Time frame: Up to 28 days or discharge and at 3 months of age
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Naim Shehadeh, Prof. study director
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Formulation of Insulin in people with Premature Birth of Newborn, run by Elgan Pharma Ltd. at 1 site in Israel.
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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early. 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?
Number of days to achieve complete enteral feeding (time frame: Up to 28 days or discharge and at 3 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2021.