clinical trial comparing the long term outcomes of post discharge probiotic treatment in moderately premature infants

Long term growth and developmental outcomes following post discharge multistrain probiotic supplementation in preterm neonates less than 33 weeks of gestation- An RCT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/011033

Enrollment

202

Registered

2017-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Probiotic: Multistrain probiotic 1gm pack containing 1.25 billion cells of Lactobacillus acidophilus, Lactobacillus rhamnosus, and Bifidobacterium longum and Sacchromyces boulardi.-avai

Eligibility

Inclusion criteria

Inclusion criteria: All preterm NICU graduates born less than 33 weeks of gestation will be randomised to the two study groups at 3 weeks post discharge The 3 week cutoff is because these infants routinely receive probiotics during NICU stay. A wash out period of 3 weeks might be need to rule out continued effects of initial probiotic supplementation in the placebo group.

Exclusion criteria

Exclusion criteria: Parental refusal for consent and families living out of Mumbai

Design outcomes

Primary

Measure	Time frame
Mean gain in weightTimepoint: from term till 1.5 years corrected age	—

Secondary

Measure	Time frame
Bayleys Neurodevelopmental scoreTimepoint: 1.5 years;Body mass indexTimepoint: 3 monthly till 1.5 years;Centiles for weight, length,head circumferenceTimepoint: 3 monthly till 1.5 years;Serum lipid profile, plasma glucose, serum insulinTimepoint: 1.5 years;waist hip ratioTimepoint: 3 monthly till 1.5 years;Weight ,length, head circumferenceTimepoint: 3 monthly till 1.5 years;Z score for weight,length,head circumferenceTimepoint: 3 monthly till 1.5 years	—

Measure

Time frame

Bayleys Neurodevelopmental scoreTimepoint: 1.5 years;Body mass indexTimepoint: 3 monthly till 1.5 years;Centiles for weight, length,head circumferenceTimepoint: 3 monthly till 1.5 years;Serum lipid profile, plasma glucose, serum insulinTimepoint: 1.5 years;waist hip ratioTimepoint: 3 monthly till 1.5 years;Weight ,length, head circumferenceTimepoint: 3 monthly till 1.5 years;Z score for weight,length,head circumferenceTimepoint: 3 monthly till 1.5 years

—

Countries

India

Contacts

Public ContactHaribalakrishna Balasubramanian

Surya childrens medicare Pvt Ltd

komal.softee@gmail.com08078655821

Outcome results