Research Gaps In Neonatology: An India-First Lens With Global Context - Dr Arti Maria

Health research in LMICs is too often steered by donor agendas rather than national needs, risking inequity and inefficiency. Systematic, transparent prioritization is essential; the Child Health and Nutrition Research Initiative (CHNRI) method offers a replicable way to rank options (answerability, effectiveness, deliverability, equity, cost) with broad stakeholder input, and India has applied it nationally via ICMR–INCLEN.

Neonatology at an inflection point.

Survival has improved, yet intact survival and thriving lag—especially for small and sick newborns (SSNBs). The 2025 Lancet Child & Adolescent Health Commission calls for a “re-boot” of neonatal innovation, citing stalled pipelines for medicines/devices, weak cross-sector collaboration, and regulatory bottlenecks that slow translation from bench to bedside; it urges coordinated investment by regulators, funders, industry, and clinicians, with families as research partners. Your invited comment, “The future of neonatology: bridging gaps, shaping realities,” underscores the opportunity for LMIC-led models to shape the global agenda.

Global gaps

• Innovation and translation. Neonates remain “therapeutic orphans”: too many interventions are extrapolated from older populations and never adequately tested in newborns. The Commission urges fit-for-purpose neonatal trials, device-development pathways, and adaptive regulatory science.

• Outcomes beyond discharge. Long-term neurodevelopment/ECD is inconsistently measured; post-discharge follow-up is fragmented. A recent India-focused systematic review shows limited, heterogeneous evidence linking structured high-risk follow-up (HRIF) to outcomes—signalling both service and research gaps.

• Feeding and growth of the most vulnerable. Evidence remains thin for identifying and managing growth faltering among infants <6 months—a critical period for preterm and low-birth-weight infants transitioning home. Protocols, case definitions, and effective interventions need clarity.

The Born Too Soon document has recommended a shared, cross-cutting agenda should pair condition-specific priorities (prevent and manage preterm complications) with delivery enablers (measurement, platforms, financing, and equity)—to avoid “pilotitis” and align funders and programs around scalable studies.

India/LMIC-specific gaps

• Workforce and nursing science. Neonatal nursing research from LMICs is sparse and often descriptive; implementation-ready studies on staffing models, competencies, family-integrated care, and respectful care are rare—despite their outsized impact on bedside quality.

• Follow-up pathways and registries. India lacks standardized, linked, multi-site registries that follow SSNBs from SNCU discharge through early childhood; structures, processes, and outcome capture vary widely, limiting a learning-health-system approach.

• Newborn screening and precision care. NBS programs show heterogeneity in panels, financing, counselling, and quality control; scale-up requires context-specific panels, cost-effectiveness and equity analyses, and robust linkage-to-care—not merely detection.

• Priority-setting vs traction. India has articulated newborn priorities through ICMR–INCLEN CHNRI, spanning facility-based care, prematurity, infection, and nutrition—but translation into funded, multi-site pragmatic trials remains uneven; regulatory enablers for neonatal products are nascent.

What an India-led agenda could deliver (next 3–5 years)

• Pragmatic, multi-site trials embedded in FBNC/SNCU care (feeding protocols, KMC adaptations for unstable/very preterm infants; infection-prevention bundles), using core outcome sets that include ECD metrics.

• A national high risk infant follow up network linking SNCU discharge to ECD services, capturing growth, neurodevelopment, caregiver practices, and rehospitalization; integrate digital tools for reminders/remote screening.

• A neonatal device/monitoring pipeline tailored to LMIC constraints (contactless vitals, simplified CPAP, low-cost diagnostics) with human-factors testing and regulatory science embedded from the start.

• Nursing-led implementation research on staffing, mentorship, and family-integrated care models, tied to quality-of-care and equity outcomes.

• NBS implementation studies: phased expansion with context-specific panels, counselling standards, cost-effectiveness, and time-to-treatment and family-experience metrics.

Bottom line. The global and India-specific research gap is less about ideas than about systems: enabling platforms for neonatal trials/devices, longitudinal outcome measurement, and cross-sector partnerships. India can lead by operationalizing an integrated, facility-to-home research architecture that turns routine care into learning care—bridging realities and building futures for SSNBs.

References

1. De Luca D, Modi N, Davis PG, Abman SH, Vento M, Allegaert K, et al. The Lancet Child & Adolescent Health Commission on the future of neonatology. Lancet Child Adolesc Health. 2025;9(8):578–612. doi:10.1016/S2352-4642(25)00106-3.

2. Maria A. The future of neonatology: bridging gaps, shaping realities. Lancet Child Adolesc Health. 2025;9(8):521–522. doi:10.1016/S2352-4642(25)00167-1.

3. Arora NK, Mohapatra A, Gopalan HS, Wazny K, Thavaraj V, Rasaily R, et al. Setting research priorities for MNCH&N in India: a CHNRI exercise by ICMR and INCLEN. J Glob Health. 2017;7(1):011003. doi:10.7189/jogh.07.011003.

4. Siva N, Praharaj M, Jena S, Tripathy P, Nayak BS, Lewis LE. High-risk neonatal follow-up care in India: a systematic review. J Neonatal Nurs. 2025;31(1):95–106. doi:10.1016/j.jnn.2024.07.020.

5. Tomori C, O’Connor DL, Ververs M, Orta-Aleman D, Paone K, Budhathoki C, et al. Critical research gaps in treating growth faltering in infants <6 months. PLOS Glob Public Health. 2024;4(1):e0001860. doi:10.1371/journal.pgph.0001860.

6. Amundsen MMM, Little M, Clark N, Marcellus L. Neonatal nursing research in LMICs: a scoping review. J Neonatal Nurs. 2024;30(6):583–600. doi:10.1016/j.jnn.2024.05.004.

7. Born Too Soon Initiative. Research priorities for reducing deaths and disability in preterm babies .

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