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Impact of tele-consultation for following up newborns during COVID-19 pandemic

Impact of teleconsultation for neonatal follow-up during COVID-19 pandemic: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025492
Enrollment
2978
Registered
2020-05-31
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

None listed

Interventions

Intervention1: Tele-consultation arm: Caregivers of enrolled infants being discharged from hospital shall participate in a teleconsultation visit with neonatal providers within one week of discharge.
comfort with the physician during teleconsultation, whether not their questions were answered and their overall satisfaction with the visit Control Intervention1: Standard arm: At the time of dischar

Sponsors

JIPMER Intramural fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with gestational age at birth greater than or equal to 34 weeks Delivered in JIPMER hospital Discharged home within the first week of life

Exclusion criteria

Exclusion criteria: 1. Need for NICU stay for 7 days or more 2. Major congenital anomalies 3. Postnatal morbidities (respiratory distress syndrome, neonatal sepsis, need for ventilation more than 24 hours, moderate or severe hypoxic iscahemic encephalopathy etc) requiring enrollment and follow up in high risk follow up clinic of JIPMER as per unit policy 4. Parents who do not have a telephone or mobile services to enable tele consultation 5. Unwilling to provide consent

Design outcomes

Primary

MeasureTime frame
Need for emergency room visit or re-hospitalizationTimepoint: At 28 days of life for term neonates and at 4 weeks corrected age for late preterm neonates

Secondary

MeasureTime frame
Incidence of post discharge neonatal mortality (death after hospital discharge and within 28 days of life)Timepoint: At 28 days of life in term neonates and at 4 weeks of corrected age in late preterm neonates;Need for emergency room visit or re-hospitalizationTimepoint: At 28 days of life in term neonates and at 4 weeks corrected age in late preterm neonates;To evaluate reasons and risk factors for mortality and emergency room visit/re-hospitalization among the enrolled neonatesTimepoint: At 28 days of life in term neonates and at 4 weeks of corrected age in late preterm neonates;To evaluate the number of occasions that a teleconsultation helps in averting an additional visit to a health facility or enables an earlier medical visit â?? In the telehealth groupTimepoint: At 28 days of life or at 4 weeks corrected age;To study the parental satisfaction with tele-consultation evaluated on three aspects using Likert scale; comfort with the physician during teleconsultation, whether not their questions were answered and their overall satisfaction with the visit- in the telehealth groupTimepoint: End of follow up period (28 days of life or 4 weeks corrected age)

Countries

India

Contacts

Public ContactSindhu Sivanandan

Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research

drsindhusivanandan@gmail.com9968935020

Outcome results

None listed

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