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comparing death and problems faced by babies born less than 800 grams between two periods (2017-2020 and 2021-2023) in a high quality newborn intensive care unit

Comparative analysis of short term outcomes in Extremely Low Birth Weight infants <800grams (micro-preemies) in a tertiary care NICU between two time periods : a retrospective cohort study - -

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/10/075085
Enrollment
206
Registered
2024-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr Meena kadiyala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates with birth weight less than 800 grams (micro-preemie) and confirmed gestational age of more than 23 0/7 weeks given full NICU care after shared decision making of obstetric/neonatal team with family of baby will be included in the study.

Exclusion criteria

Exclusion criteria: Preterm neonates with lethal or complicated malformations , chromosomal anomalies. Death/discontinuation of treatment within 12 hours of delivery will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Proportion of neonates who had survived till discharge (survival rates) Timepoint: Birth to discharge—

Secondary

MeasureTime frame
Short term morbidities like, Respiratory Distress Syndrome [RDS] Hemodynamically significant Patent ductus arteriosus [hs-PDA] Necrotizing Enterocolitis [NEC] (bell stage II or greater) Intraventricular Hemorrhage [IVH] grade = II Periventricular leukomalacia [PVL] Pulmonary hemorrhage Any sepsis [culture proven , screen positive, clinical sepsis] Dys-electrolytemia Moderate to severe bronchopulmonary dysplasia [BPD] Retinopathy Of Prematurity [ROP] during hospital stay Osteopenia of prematurity Neonatal cholestasis Anaemia of prematurity Coagulopathy Thrombocytopenia Timepoint: Birth to discharge;Age (in days) for discharge from the hospital in survivors Timepoint: Birth to discharge;Feeding related parameters like, Feed intolerance with number of feed interruptions Time to reach full enteral feeds Time to start paladai feeds and to reach full paladai feeds Probiotic usage Timepoint: Birth to discharge;Requirement of Therapeutic modalities like, Ventilation Surfactant replacement therapy Total parenteral nutrition [TPN] Antibiotics for sepsis PDA medical management / PDA ligation Blood products transfusion (packed red cells, fresh frozen plasma) Steroids for BPD Laser therapy or intravitreal injections for ROP   Timepoint: Birth to discharge—

Countries

India

Contacts

Public ContactDr Giridhar Sethuraman

Chettinad Hospital and Research Institute

giridharsethu@gmail.com9841027228

Outcome results

None listed

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