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NCT00331201
SAFEstart Treatment for NICU Patients With Feeding Intolerance; a Phase II Randomized, Controlled Trial
Phase 2 trial testing SAFEstart in Feeding Intolerance in 20 participants. Completed in 1 April 2006.
Quick facts
| Lead sponsor | Intermountain Health Care, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 July 2005 |
| Estimated completion | 1 April 2006 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SAFEstart — full drug profile →
Conditions studied
- Feeding Intolerance — all drugs for Feeding Intolerance →
- Abdominal Distention — all drugs for Abdominal Distention →
- Gastric Residual — all drugs for Gastric Residual →
- Emesis and Diarrhea — all drugs for Emesis and Diarrhea →
Sponsor
Intermountain Health Care, Inc. — full company profile →
Who can join
Eligibility, any sex, with Feeding Intolerance or Abdominal Distention. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- The primary outcome measure will be the number of calories/kg taken enterally during the seven days after the four days of SAFEstart (or sham) treatment
Sponsor's own description
Feeding intolerance is a common problem in the NICU. Feeding intolerance complicates the hospitalization, lengthens the hospital stay, and adds substantially to the cost of care. We developed a method aimed at treating intestinal villous atrophy. We accomplished preclinical testing of the product, and four Phase I clinical trials, including two at McKay-Dee Hospital in 2004. Our preparation is a sterile, isotonic, solution that simulates human amniotic fluid in electrolyte composition, albumin concentration, and two enterocyte growth factors that are present in human amniotic fluid; erythropoietin and granulocyte colony-stimulating factor. We termed the product SAFEstart, using the acronym Simulated Amniotic Fluid for Enteral administration. This trial on the efficacy and safety of SAFEstart administration as a treatment for neonates who have feeding intolerance. Hypothesis is that infants with feeding intolerance, randomized to the SAFEstart will have a greater enteral calories per kilogram per day for the seven days following conclusion of the SAFEstart administration.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00331201
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Feeding Intolerance
Currently open trials in the same condition.
- NCT06632314 — Impact of Enteral Feeding on Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants · NA · active not recruiting
Other Intermountain Health Care, Inc. trials
Trials by the same sponsor.
- NCT07334795 — Intermountain Stewardship in Community Outpatient Settings-Resources & Engagement-Pediatrics · active not recruiting
- NCT07348289 — PIVO Use for Blood Cultures in the Emergency Department · recruiting
- NCT06865781 — Vital Signs Reduction Study · NA · active not recruiting
- NCT05936021 — Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease U · NA · unknown
- NCT05141396 — Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00331201 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Intermountain Health Care, Inc.
- Last refreshed: 27 November 2006
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00331201.
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