Thayyil, Sudhin http://orcid.org/0000-0001-8795-5165
,
Oliveira, Vania
Lally, Peter J.
Swamy, Ravi
Bassett, Paul
Chandrasekaran, Mani
Mondkar, Jayashree
Mangalabharathi, Sundaram
Benkappa, Naveen
Seeralar, Arasar
Shahidullah, Mohammod
Montaldo, Paolo
Herberg, Jethro
Manerkar, Swati
Kumaraswami, Kumutha
Kamalaratnam, Chinnathambi
Prakash, Vinayagam
Chandramohan, Rema
Bandya, Prathik
Mannan, Mohammod Abdul
Rodrigo, Ranmali
Nair, Mohandas
Ramji, Siddarth
Shankaran, Seetha
Funding for this research was provided by:
Bill and Melinda Gates Foundation (OPP1069985)
Weston Garfield Endowment (F28312)
Article History
Received: 24 March 2017
Accepted: 29 August 2017
First Online: 18 September 2017
Ethics approval and consent to participate
: Imperial College Research Ethics Committee (Central Ethics Committee for the HELIX trial) has approved the trial (ICREC Reference 15IC2564; 20 April 2015). The REC approvals at the following recruiting centres have already been obtained: Calicut Medical College, Kerala, India (IRC/2015/Protocol/57; 12 June 2015); Indira Gandhi Institute of Child Health, Bangalore, India (IEC01062015; 1 June 2015); Lokmanya Tilak Municipal Medical College staff and research society (IEC/30/15; 17 June 2015); Madras Medical College Institutional Ethics Committee (IEC08072015; 7 July 2015); Maulana Azad Medical College Institutional Ethics Committee (IEC/MAMC/52/1/2016; 30 March 2016); Bangabandhu Sheikh Mujib Medical University Institutional Review Board (BSMMU/2016/6885; 29 June 2016); and Ethics Review Committee, University of Kelaniya (P/109/03/2017; 3 April 2017) (Table InternalRef removed). The Health Ministry’s Screening Committee (HMSC) of India and the Indian Council of Medical Research (ICMR) have also approved the proposal. All original trial documentation and any subsequent amendments will be approved by the Sponsor (Imperial College London) and by the relevant ethical bodies, before their implementation. Informed written parental consent will be obtained from parents of next kin of recruited babies and the consenting process will be video-recorded.Table removed
: Written informed consent was obtained from the parents for publication of their individual details and any accompanying images in this manuscript. The consent form is held by the authors and in the patients’ clinical notes and is available for review by the Editor-in-Chief.
: The authors declare that they have no competing interests.
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