Randomized controlled trial on effectiveness of mHealth (mobile/smartphone) based Preterm Home Care Program on developmental outcomes of preterms: Study protocol.

AIM: To describe a randomized controlled trial protocol designed to evaluate the effectiveness of mobile health based Preterm Home Care Program (mHealthPHCP) known as "NeoRaksha" mobile health application in improving parent-infant-interaction, growth and development of preterms.

DESIGN: A prospective, randomized controlled clinical trial. The protocol is approved and funded by Department of Biotechnology, Government of India on 2 August 2016.

METHODS: A total of 300 preterm-mother dyads admitted to neonatal intensive care unit of a tertiary care hospital will be recruited and randomized to intervention and control group. The intervention group would receive mobile health based Preterm Home Care Program and the control group would receive standard preterm care. Intervention group will be followed up at home by community health workers known as Accredited Social Health Activist who will be trained in using the NeoRaksha mobile health application. Preterms outcomes will be assessed during follow-up at hospital.

DISCUSSION: Supporting continuity of preterm care is vital as parents and preterms experience transition from Neonatal Intensive Care unit to their home. Empowering mothers and community health workers by integrating mobile technology into health care can help promote healthy preterms, enhance development outcomes and follow-up, which in turn can reduce the mortalities, morbidities, and disabilities associated with prematurity.

IMPACT: The results of this study could open up new horizons in integrating hospital and home based preterm care through technology, which paves way to scale up the model across the countries.