Sinha, Anju Pradhan http://orcid.org/0000-0002-0830-7723
,
Gupta, Subodh S.
Poluru, Ramesh
Raut, Abhishek V.
Arora, Narendra Kumar
Pandey, Ravindra Mohan
Sahu, Aditya Ranjan
Bethou, Adhisivam
Sazawal, Sunil
Parida, Sailajanandan
Bavdekar, Ashish
Saili, Arvind
Gaind, Rajni
Kapil, Arti
Garg, Bishan S.
Maliye, Chetna
Jain, Manish
Mahajan, Kamlesh S.
Dhingra, Pratibha
Pradhan, Keshab C.
Kawade, Anand S.
Nangia, Sushma
Mukherjee, Ajit
Rasaily, Reeta
Sharma, Radhey Shyam
Funding for this research was provided by:
Medical Research Council (MR/S004912/1)
Article History
Received: 22 September 2020
Accepted: 15 March 2021
First Online: 1 April 2021
Declarations
:
: This manuscript describes the protocol for the conduct of a phase III, multicentric, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of a multi-strain probiotic for prevention of neonatal sepsis in 0–2-month-old LBW infants in India and has been approved for submission by all investigators for publication. No individual participant data is presented in the manuscript; therefore, consent from participants is not applicable.
: Aditya Ranjan Sahu worked as a consultant with Next Gen Pharma India Pvt. Ltd. All authors declare that they have no competing interests.