Probiotics Reduce Incidence of Necrotizing Enterocolitis for Very Low Birth Weight Infants

NCT00540033 | Terminated Phase 2 DMC

• 1 other identifier: DMR94-IRB-14
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

We investigate the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective, masked, multi-center randomized control trial will be conducted level III neonatal center to evaluate the beneficial effects of probiotics for NEC among VLBW (\<1500 g) infants. VLBW infants who start to feed enterally are eligible and are randomized into 2 groups after parental informed consents were obtained. Infants in the study group are fed with Infloran (Lactobacillus acidophilus and Bifidobacterium bifidus) with breast or formula milk twice daily for 6 weeks. Infants in the control group are fed with breast or formula milk alone. The clinicians caring for the infants are blinded to the group assignment. The primary outcome measurement is death or NEC (≧stage 2).

Conditions

Enterocolitis, Necrotizing

Keywords

probiotics; necrotizing enterocolitis; preterm very low birth weight infants (VLBW)

Outcome Measures

Primary Outcomes (1)

• The primary outcome measurement was death or NEC (≧stage 2)

  From April 1, 2005 to May 30, 2007

Secondary Outcomes (1)

• Secondary outcome were culture proved sepsis, chronic lung disease, periventricular leukomalacia (PVL) , weight gain per week, duration of TPN, lengthy of stay, cost effective analysis.

  From April 1, 2005 to May 30, 2007,

Study Arms (1)

2

EXPERIMENTAL

Study arm was fed with probiotics as infloran 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks; the control arm was fed with breast milk or mixed feeding without probiotics.

Dietary Supplement: infloran

Interventions

infloran DIETARY_SUPPLEMENT

Study group was fed with probiotics as infloran 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks;

2

Eligibility Criteria

• Age: 1 Day - 3 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm VLBW infants (birth weight \< 1500 gm) who are enterally fed are eligible for the trial.

You may not qualify if:

• Preterm VLBW infants who have severe asphyxia (stage III), fetal chromosome anomalies, fetal cyanotic congenital heart disease, congenital intestine atresia, gastroschisis and omphalocele are excluded.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Department of Pediatrics, Children Hospital, China Medical University, Taichung, Taiwan

Taichung, Taichung,, 404, Taiwan

Location

Related Publications (1)

• Lin HC, Hsu CH, Chen HL, Chung MY, Hsu JF, Lien RI, Tsao LY, Chen CH, Su BH. Oral probiotics prevent necrotizing enterocolitis in very low birth weight preterm infants: a multicenter, randomized, controlled trial. Pediatrics. 2008 Oct;122(4):693-700. doi: 10.1542/peds.2007-3007.

  PMID: 18829790 DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• HUNG-CHIH LIN, MD

  Department of Pediatrics, Children Hospital, China Medical University, Taichung, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 5, 2007
• Study Start: February 1, 2005
• Study Completion: June 1, 2007
• Last Updated: October 5, 2007

Record last verified: 2007-10

Locations

TW (1)