Prevention of neonatal sepsis in low birth weight infants

Conditions

None listed

Sinha AP, Raja D, Mahajan KS, Sharma P, Gupta SS, Poluru R, Kawade AS, Dayma G, Sazawal S, Bavdekar A, Parida S, Nangia S, Raut AV, Bethou A, Devi P, Gorpade M, Fatima T, Nayak R, Kapil A, Azam M, Khan PA, Pandey RM, Arora NK, ProSPoNS Study Group.

2024-07-05

10.1186/s13063-024-08298-0

Study protocol for economic evaluation of probiotic intervention for prevention of neonatal sepsis in 0–2-month old low-birth weight infants in India: the ProSPoNS trial

Anju Sinha, Pankaj Bahuguna, Subodh S. Gupta, Yamini Priyanka Kuruba, Ramesh Poluru et al. (14 authors)

BMJ Open2023-03-014 citations

10.1136/bmjopen-2022-068215

Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0-2-month-old low birth weight infants in India-the "ProSPoNS" Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial.

Sinha AP, Gupta SS, Poluru R, Raut AV, Arora NK, Pandey RM, Sahu AR, Bethou A, Sazawal S, Parida S, Bavdekar A, Saili A, Gaind R, Kapil A, Garg BS, Maliye C, Jain M, Mahajan KS, Dhingra P, Pradhan KC, Kawade AS, Nangia S, Mukherjee A, Rasaily R, Sharma RS, ProSPoNS study Group.

2021-04-018 citations

10.1186/s13063-021-05193-w

Interventions

Intervention1: Vivomixx Drops i.e. Lactic acid bacteria and Bifidobacteria drop with medium chain triglyderide oil. 1. Each bottle cap contains at least 50 Billion Lactic acid bacteria and Bifidobact

Eligibility

Inclusion criteria

Inclusion criteria: 1. Birth weight: =1500 g to =2500 g 2. Age of the new-born Day 3-7 on recruitment i.e. not later than 7th day 3. Stable clinical condition as assessed by physician and accepting feeds orally (where stable is defined as, does not require intravenous fluids and vasopressor medication to maintain circulation and accepts oral feeding or breastfeeding). 4. The mother (with the new-born) is planning to stay in study area for a period of at least two months

Exclusion criteria

Exclusion criteria: 1. New born with extreme prematurity i.e. = 34 weeks 2. New born with illness requiring prolonged hospitalisation and interference with oral feeding 3. Presence of a gross congenital malformation incompatible with life 4. Parent or Legally authorized representative (LAR) not providing written consent

Design outcomes

Primary

Measure	Time frame
1. Sepsis 2. Possible serious bacterial infections (PSBIs)Timepoint: 60 days	—

Secondary

Measure	Time frame
a. Stool colonization patterns at baseline day 0, day 21 and day 60 in a sub-sampleTimepoint: 60 days;b. Death and late onset sepsis: Comparison of all-cause deaths and late onset sepsis between the intervention and control groupsTimepoint: 30 days;c. Clinical severe infection: One or more clinical signs - not feeding well, fever (temperature = 38 °C), low body temperature (less than 35.5 °C), severe chest in-drawing,the movement only when stimulated as confirmed by study physician.Timepoint: 30 days;d. Critical Illness: One or more of clinical signs - convulsions, unable to feed at all, no movement on stimulation, unable to cry, bulging fontanelle and cyanosis as confirmed by study physician.Timepoint: 30 days;e. Cost effectiveness of the probiotics intervention would be taken up as a sub-study to inform policy. Timepoint: 30 days	—

Measure

Time frame

a. Stool colonization patterns at baseline day 0, day 21 and day 60 in a sub-sampleTimepoint: 60 days;b. Death and late onset sepsis: Comparison of all-cause deaths and late onset sepsis between the intervention and control groupsTimepoint: 30 days;c. Clinical severe infection: One or more clinical signs - not feeding well, fever (temperature = 38 °C), low body temperature (less than 35.5 °C), severe chest in-drawing,the movement only when stimulated as confirmed by study physician.Timepoint: 30 days;d. Critical Illness: One or more of clinical signs - convulsions, unable to feed at all, no movement on stimulation, unable to cry, bulging fontanelle and cyanosis as confirmed by study physician.Timepoint: 30 days;e. Cost effectiveness of the probiotics intervention would be taken up as a sub-study to inform policy. Timepoint: 30 days

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Countries

India

Contacts

Public ContactAnju Sinha

Indian Council of Medical Research (Hqrs.)

apradhandr@gmail.com011-26589493

Outcome results