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A clinical trial to study the effects of mobile application based preterm home care program for premature infants

Effectiveness of a mHealth (mobile/smart phone) based Preterm Home Care Program (mHealthPHCP/NeoRaksha) on the developmental outcomes of preterms.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/012259
Enrollment
300
Registered
2018-02-28
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

Health Condition 1: Z764- Other boarder to healthcare facility Health Condition 2: null- Preterm Infants

Interventions

Intervention1: Mobile health based Preterm Home Care Programme (mHealthPHCP/NeoRaksha): mHealthPHCP/NeoRaksha is mobile health application which will be given to mothers in the intervention group for

Sponsors

Department of Biotechnology Government of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants born at less than 37 weeks of gestation. Mothers of these preterm infants who are admitted in the NICU, Kasturba Hospital for preterm management and mother has at least one smart phone at home and are willing to give consent, can read and speak English or Kannada, a resident of in Udupi district.

Exclusion criteria

Exclusion criteria: Preterms having severe handicapping conditions including: Grade III or IV Intraventricular haemorrhage, sepsis; asphyxia; major congenital anomalies associated with a poor neurodevelopment outcome.

Design outcomes

Primary

MeasureTime frame
Growth of preterm infants which includes weight in grams, height in cms and head circumference in cms. Development of preterm infants assessed in terms of cognition, language and motor development Mother-infant interaction Compliance to mHealthPHCP/NeoRakshaTimepoint: At 3, 6, 9 and 12 months of corrected age.

Secondary

MeasureTime frame
Trend in follow upTimepoint: At 12 months of corrected age of the baby

Countries

India

Contacts

Public ContactDr Leslie Lewis

Manipal College of Nursing MAHE Manipal

baby.s@manipal.edu9448174791

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026