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A study comparing a new family-centered care program with standard care to improve health and recovery of premature newborns in the NICU.

Evaluation of comparative efficacy of modified Family-Centered Care (FCC) Programs vs existing Family Family-Centered Care on premature Neonatal Outcomes: A Randomized Controlled Trial. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094005
Enrollment
88
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Modified Family centred Care: The modified FCC program involves structured family-centered care enhanced with technology-based approaches. Parents are trained and actively encouraged to

Sponsors

DUTTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH
Lead Sponsor
JAWAHAR LAL NEHRU MEDICAL COLLEGE Wardha
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates admitted to the NICU at Wardha and expected to have a NICU stay exceeding 48 hours. ii. Families or primary caregivers who are willing to participate in the FCC iii. Without congenital anomalies or conditions or requiring specialized treatment not compatible with FCC interventions.

Exclusion criteria

Exclusion criteria: Neonates whose surgeries has been done or there is a plan for surgery which might interfere with provision of FCC? ii. Language or logistic issues viz parents and NICU staff not able to effectively communicate with each other iii. Newborns who are expected to die or discharge within 48 hours.

Design outcomes

Primary

MeasureTime frame
FAMILY SATISFECTION NICU STAY DURATION IMPROVED BABY OUTCONE VIZ WEIGHT GAIN, INCIDENCE OF SEPSIS ETCTimepoint: 1. Neonatal weight gain: assessed at baseline, day 7, day 14, and NICU discharge. 2. Duration of NICU stay: evaluated at NICU discharge. 3. Neonatal morbidity and complications: sepsis, apnea, hypothermia, feeding intolerance assessed daily and at discharge. 4. Neonatal mortality: evaluated at NICU discharge. 5. Parental satisfaction score: assessed at NICU discharge.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactVIRENDER VERMA

DUTTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH

AVARMA2055@gmail.com9070437333

Outcome results

None listed

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