Prevention of Infection in Indian Neonates - Phase II Probiotics Study

NCT00518596 | Completed Phase 2

• 3 other identifiers: GN 07 Phase IIU01HD040574R01HD053719
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 3

Brief Summary

India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.

Conditions

Sepsis

Keywords

Neonatal; Sepsis; Global Network; Probiotics; India; International; Maternal and child health

Outcome Measures

Primary Outcomes (3)

• Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.

  28 days

• Clinical safety (including sepsis and death) and tolerance of a daily administration of oral L. plantarum probiotic supplement when used in healthy full-term neonates.

  28 days

• Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.

Secondary Outcomes (1)

• Feasibility of the future community study (consent and retention rates, completeness of stool sampling, ability to complete the study in the home for infants discharged early).

Study Arms (2)

Probiotic Arm

EXPERIMENTAL

Newborn infants' ≥ 35 weeks of gestation and ≥1800g, given L. plantarum preparations orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter.

Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)

Control Arm

PLACEBO COMPARATOR

Newborn infants' ≥ 35 weeks of gestation and ≥1800g, receiving placebo preparations (a control solution of sterile 2.0 cc 5% dextrose-saline)orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter.

Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)

Interventions

Probiotic supplementation (Lactobacillus plantarum) DIETARY_SUPPLEMENT

GastroPlan capsules from a single lot will be used. The intervention consists of L. plantarum reconstituted in sterile 2.0 cc of 5% dextrose-saline, administered orally using an opaque-amber syringe.

Also known as: Gastroplan

Control Arm; Probiotic Arm

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants ≥ 35 weeks and ≥1800g born in the hospital
• Infants \> 12 hours and \< 72 hours of age at enrollment
• Infants likely to be hospitalized for 5-7 days without antibiotic treatment
• Informed consent by one parent or guardian
• Infants begun breastfeeding

You may not qualify if:

• Antibiotic therapy prior to enrollment
• Evidence or suspicion of clinical sepsis before randomization
• Inability (as determined by the physician) to tolerate oral feeding of study supplement
• Presence of major congenital anomalies
• Infant's home is \>30km away from hospital A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• Global Network for Women's and Children's Health Research: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• National Cancer Institute (NCI): collaborator
• RTI International: collaborator
• All India Institute of Medical Sciences: collaborator
• TN Medical College, Mumbai: collaborator
• Department of Health and Family Welfare, Orissa: collaborator
• SCB Medical College, Cuttack: collaborator
• Capital Hospital, Bhubaneswar: collaborator
• Ispat General Hospital, Rourkela: collaborator
• Kalinga Hospital, Bhubaneswar: collaborator
• University of Maryland: collaborator

Study Sites (3)

Capital Hospital

Bhubaneswar, Odisha, India

Location

Kalinga Hospital

Bhubaneswar, Odisha, India

Location

Ispat General Hospital

Rourkela, Odisha, India

Location

Related Links

• Global Network for Women's and Children's Health Research
• RTI International

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pinaki Panigrahi, M.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 21, 2007
• Study Start: July 1, 2005
• Study Completion: August 1, 2006
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

IN (3)