Necrotizing EnterocolitisPhase 1NCT03302338
Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries
A Phase 1 study testing SAFE group in people with Necrotizing Enterocolitis, run by Rania Ali El-Farrash at 1 site in Egypt.
Trial summary
Amniotic fluid plays a significant role in fetal gut maturation and development. 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… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- SAFE group
- 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
- Jul 2015to Oct 2018
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with operable congenital bowel abnormalities
Who cannot join
- Critically ill babies.
- Presence of any contraindications to enteral feeding
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 1138
Rania A El-Farrash, MD, 00201222208550, raniafarrash@hotmail.com
safaa A El-aziz, Msc
About this study
Official title: Simulated Amniotic Fluid Like Solution Enterally Administrated in Neonates Recovering From GIT Surgeries
Amniotic fluid plays a significant role in fetal gut maturation and development. 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 neonates recovering from surgery for congenital bowel abnormalities, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in neonates recovering from GIT surgeries.
Read the detailed description
Neonates with congenital GIT anomalies will participate after being operated.
Participants will be followed for the duration of hospital stay until discharge or death.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- SAFE group, placebo group
- Keywords
- Feeding intolerance, Simulated amniotic fluid like solution, 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.
SAFE groupDrug
Also called simulated amniotic fluid like solution 20cc/kg/day enterally
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
placebo groupDrug
Also called distilled water
distilled water 20 ml/kg/day for maximum of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| SAFE group | Experimental | SAFE group: 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: SAFE group |
| Placebo | Placebo comparator | Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given. Receives: Drug: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of feeding intolerance
Feeding intolerance defined as distended loops of bowel, bilious vomiting, large pre-feeding gastric residuals more than 20% of each feed, diarrhea, occult or gross blood in stools, abdominal wall erythema or ecchymosis
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Necrotizing enterocolitis
- Clinical signs of suspected NEC (abdominal distension, increased volume of gastric aspirate, bile stained aspirate, and / or apnea or bradycardia), and Bell's modified criteria for staging (Bell et al., 1978).
Measured: The outcome measure will be assessed within 2 months
hospital stay
duration on hospitalization
Measured: through study completion, an average of 1 year
mortality
death
Measured: he outcome measure will be assessed within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study startJul 2015
- Primary completionJun 2018 (estimated)
- Study completionOct 2018 (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
- NCT03302338
- Sponsor's protocol ID
- SAFE 2013
- Status last verified
- Sep 2017
- First submitted
- 17 May 2015
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated Amniotic Fluid Like Solution Enterally Administrated in Neonates Recovering From GIT Surgeries
- ClinicalTrials.gov ID
- NCT03302338
- Acronym / sponsor ID
- SAFE 2013
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Feeding intolerance, Simulated amniotic fluid like solution, 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
- Jul 2015 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 5 Oct 2017 (actual)
- 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.
Amniotic fluid plays a significant role in fetal gut maturation and development. 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 neonates recovering from surgery for congenital bowel abnormalities, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in neonates recovering from GIT surgeries.
Detailed description
Neonates with congenital GIT anomalies will participate after being operated.
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: SAFE groupSAFE group: 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. |
| Placebo | Placebo comparator | Drug: placebo groupPlacebo group: distilled water 2.5 ml/kg every 3 hours enterally given. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates with operable congenital bowel abnormalities
Key exclusion criteria (2 listed)
- Critically ill babies.
- Presence of any contraindications to enteral feeding
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 |
|---|---|---|
| SAFE groupAlso: simulated amniotic fluid like solution 20cc/kg/day enterallysimulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days. | Drug | SAFE group |
| placebo groupAlso: distilled waterdistilled water 20 ml/kg/day for maximum of 7 days. | Drug | Placebo |
Primary outcome
Signs of feeding intolerance
Time frame: through study completion, an average of 1 year
Feeding intolerance defined as distended loops of bowel, bilious vomiting, large pre-feeding gastric residuals more than 20% of each feed, diarrhea, occult or gross blood in stools, abdominal wall erythema or ecchymosis
3 secondary outcomes
Necrotizing enterocolitis
Time frame: The outcome measure will be assessed within 2 months
hospital stay
Time frame: through study completion, an average of 1 year
mortality
Time frame: he outcome measure will be assessed within 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
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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 SAFE group 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 5 Oct 2017. 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?
Signs of feeding intolerance (time frame: through study completion, an average of 1 year). 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 5 Oct 2017.