Necrotizing EnterocolitisPhase 1NCT02405637
Simulated Amniotic Fluid In Preventing Feeding Intolerance and Necrotizing Enterocolitis VLBW Neonates
A Phase 1 study testing simulated amniotic fluid 20cc/kg/day enterally and distilled water in people with Necrotizing Enterocolitis, run by Rania Ali El-Farrash at 1 site in Egypt.
Trial summary
The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.Growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- simulated amniotic fluid 20cc/kg/day enterally and distilled water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 1
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants with birth weight 1.5 Kg
Who cannot join
- Congenital or acquired anomaly of the gastrointestinal tract (i.e., omphalocele, tracheoesophageal fistula, intestinal perforation).
- Other major congenital anomalies (congenital heart disease, neural tube defect, congenital diaphragmatic hernia, trisomy, etc.).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Cairo Governorate, 1138
Rania A El-Farrash, MD, 00201222208550, raniafarrash@hotmail.com
Ahmed S Auda, Msc
About this study
Official title: Enteral Administration of a Simulated Amniotic Fluid In Preventing Feeding Intolerance And Necrotizing Enterocolitis In Very Low Birth Weight Neonates
The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.Growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding intolerance is a common problem among premature neonates, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in premature neonates.
Read the detailed description
Very Low Birth Weight (VLBW) neonates.
Participants will be followed for the duration of hospital stay until discharge or death.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- simulated amniotic fluid 20cc/kg/day enterally, distilled water
- Keywords
- Feeding intolerance, Simulated amniotic fluid, Necrotizing enterocolitis
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulated amniotic fluid 20cc/kg/day enterallyDrug
Also called SAFE solution
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
distilled waterDrug
distilled water 20 ml/kg/day for maximum of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| SAFE group | Experimental | simulated amniotic fluid 20cc/kg/day enterally divided according to number of feds (syringe for every fed). This amount provides enteral 4.5μg rhG-CSF / kg/day and enteral 88IU rhEPO / kg/day. Receives: Drug: simulated amniotic fluid 20cc/kg/day enterally |
| placebo | Placebo comparator | distilled water 2.5 ml/kg every 3 hours enterally Receives: Drug: distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rania Ali El-Farrash
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rania Ali El-Farrash, Ain Shams University
- Investigators
- Rania A El-Farrash, MD, Study director, ASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405637
- Sponsor's protocol ID
- FMASU 7/2013
- Status last verified
- Mar 2015
- First submitted
- 23 Feb 2015
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Administration of a Simulated Amniotic Fluid In Preventing Feeding Intolerance And Necrotizing Enterocolitis In Very Low Birth Weight Neonates
- ClinicalTrials.gov ID
- NCT02405637
- Acronym / sponsor ID
- FMASU 7/2013
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Feeding intolerance, Simulated amniotic fluid, Necrotizing enterocolitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rania Ali El-FarrashUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (estimated)
- First posted
- 1 Apr 2015 (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 human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.Growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding intolerance is a common problem among premature neonates, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in premature neonates.
Detailed description
Very Low Birth Weight (VLBW) neonates.
Participants will be followed for the duration of hospital stay until discharge or death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAFE group | Experimental | Drug: simulated amniotic fluid 20cc/kg/day enterallysimulated amniotic fluid 20cc/kg/day enterally divided according to number of feds (syringe for every fed). This amount provides enteral 4.5μg rhG-CSF / kg/day and enteral 88IU rhEPO / kg/day. |
| placebo | Placebo comparator | Drug: distilled waterdistilled water 2.5 ml/kg every 3 hours enterally |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature infants with birth weight 1.5 Kg
Key exclusion criteria (2 listed)
- Congenital or acquired anomaly of the gastrointestinal tract (i.e., omphalocele, tracheoesophageal fistula, intestinal perforation).
- Other major congenital anomalies (congenital heart disease, neural tube defect, congenital diaphragmatic hernia, trisomy, etc.).
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 |
|---|---|---|
| simulated amniotic fluid 20cc/kg/day enterallyAlso: SAFE solutionsimulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days. | Drug | SAFE group |
| distilled waterdistilled water 20 ml/kg/day for maximum of 7 days. | Drug | placebo |
Primary outcome
Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Necrotizing Enterocolitis
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.
Rania A El-Farrash, MD study director
ASU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing simulated amniotic fluid 20cc/kg/day enterally and distilled water in people with Necrotizing Enterocolitis, run by Rania Ali El-Farrash at 1 site in Egypt.
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 2 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 1 Apr 2015. 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 Egypt. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Rania A El-Farrash, MD (00201222208550, raniafarrash@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months (time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks). 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 1 Apr 2015.