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Clinical Trials/CTRI/2025/11/097516
CTRI/2025/11/097516
Not yet recruiting
Not Applicable

Impact of Family-Centered Care on the Incidence of Neonatal Sepsis and Duration of Hospital Stay at a Tertiary Care Neonatal Intensive Care Unit: A Quasi-experimental Study

Maharaja Agrasen Medical College Agroha Hisar1 site in 1 country60 target enrollmentStarted: December 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Maharaja Agrasen Medical College Agroha Hisar
Enrollment
60
Locations
1
Primary Endpoint
Incidence of Neonatal Sepsis

Overview

Brief Summary

This quasi-experimental study will be conducted in the NICU of a tertiary healthcare centre over six months, divided into two phases. The study follows a non-randomized, pre-post intervention design. During the first three months (pre-intervention phase), baseline data on neonatal sepsis incidence and hospital stay duration will be collected.Subsequently, Family-Centred Care(FCC) will be introduced in the NICU. Parents will be educated and trained in essential newborn care practices.Over the next three months (post-intervention phase), data will be collected from neonates admitted during this period, now receiving care under the FCC model

The incidence of neonatal sepsis and the duration of hospital stay will be compared between the pre- and post-intervention groups to evaluate the impact of FCC.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
1.00 Day(s) to 30.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • Gestational age greater than or equal to 28 weeks Admitted to NICU within 72 hour of birth At least one caretaker is available and willing to participate in the study.

Exclusion Criteria

  • Neonates transferred to or from other facilities during care Parents unwilling to participate Neonates requiring immediate surgical interventions.

Outcomes

Primary Outcomes

Incidence of Neonatal Sepsis

Time Frame: 1 weeks 10 days 2 weeks and till discharge

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Maharaja Agrasen Medical College Agroha Hisar
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Mohd Shahnazar

Maharaja Agrasen Medical College Agroha Hisar

Study Sites (1)

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