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Comparing the incidence of sepsis in NICU babies with birth weight less than 1500 grams who receive daily sponging versus those who do not receive daily sponging

Comparing the effect of no sponging versus daily sponging on incidence of late onset neonatal sepsis among very low birth weight (VLBW) neonates in neonatal intensive care unit: An open label randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/076075
Enrollment
80
Registered
2024-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: P071- Other low birth weight newborn

Interventions

Intervention1: No sponging: In this group, babies will be cleaned only when visibly soiled and no daily routine sponging will be done Control Intervention1: Daily routine sponging: In this group, babi

Sponsors

ABVIMS and Dr. RML Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All VLBW neonates admitted to NICU within 72 hours of life. 2. With informed written consent.

Exclusion criteria

Exclusion criteria: 1. Known severe congenital/ chromosomal abnormalities. 2. Hemodynamic instability.

Design outcomes

Primary

MeasureTime frame
Incidence of late onset neonatal sepsis among VLBW neonates in neonatal intensive care unit in both the groups.Timepoint: Episodes late onset neonatal sepsis will be assessed in a continuum and compared among both the groups whenever the baby gets discharged.

Secondary

MeasureTime frame
Incidence of hypothermia in both the groups.Timepoint: Every 10 minutes till temperature normalizes.;Rate of weight gain in both the groups. Timepoint: Every week till discharge.;Physiological and behavioral responses to daily sponging.Timepoint: 1 minute after intervention.;Rise in salivary cortisol levels in daily sponging group.Timepoint: 20 minutes after intervention on day 3 of life.;Composite incidence of mortality or sepsis.Timepoint: At discharge.

Countries

India

Contacts

Public ContactDr Shobhna Sharma

ABVIMS and Dr. RML Hospital New Delhi

artimaria@gmail.com9818618586

Outcome results

None listed

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