Efficacy of Multiple Strain Probiotics Reduces the Neurobehavioral Disorder in Premature Very Low Birth Weight Infants

NCT03858816 | Withdrawn

• 1 other identifier: CMUH106-REC2-102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The management protocols, clinical practices, equipment, infrastructure, and key personnel in NICU are unchanged during the study period. The data collected by each center are transmitted to the office of the principal investigator (Dr Lin) at China Medical University Hospital. Primary outcome is death or attention deficit and hyperactivity disorder (ADHD) and ASD.

Conditions

Very Low Birth Weight Infants

Keywords

probiotics; neuropsychiatric disorder; very low birth weight infants; attention deficit and hyperactivity disorder (ADHD); autism spectrum disorder (ASD)

Outcome Measures

Primary Outcomes (1)

• Incidence rate of death or ADHD and ASD

  Two years

Secondary Outcomes (1)

• Incidence rate of NEC ≧ stage 2, sepsis, severe (grade 3-4) IVH, BPD, liver function and adverse effects or intolerance and neurodevelopment impairment.

  Two years

Study Arms (2)

Mixture probiotics

EXPERIMENTAL

The probiotic contain 1 ×10\^9 CFU/1 capsule of mixture probiotics, taking 1 probiotic capsule for up to 4 months after birth.

Other: Mixture probiotics

Placebo

PLACEBO COMPARATOR

Taking 1 placebo capsule for up to 4 months after birth.

Other: Placebo

Interventions

Mixture probiotics OTHER

The mixture probiotics capsule

Mixture probiotics

Placebo OTHER

The placebo contains the same excipient ingredients but without the live bacteria.

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preterm infants ≧ 23 weeks and ≦ 32 weeks gestational age.
• Birth weight below 1500 gm and who survive to NICU.

You may not qualify if:

• Severe asphyxia (stage III)
• Fetal chromosomal anomalies
• Cyanotic congenital heart disease
• Congenital intestinal atresia
• Gastroschisis
• Omphalocele
• Active upper gastric intestinal bleeding
• Lacking/refused of parental consent
• Early onset sepsis (before the third day of life)
• Liver failure (aspartate aminotransferase, alanine aminotransferase, glutamyl transferase, direct bilirubin serum values 3-fold higher than reference range)
• Fasted for \>3 weeks.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Department of Pediatrics, Children Hospital, China Medical University

Taichung, 404, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: June 14, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

TW (1)