EVALUATION OF COMPARATIVE EFFICACY OF MODIFIED FAMILY-CEN TERED CARE (MFCC) VERSUS STANDARD FAMILY-CENTERED CARE ON PREMATURE NEONATAL OUTCOMES: PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL
Authors: Dr. Virender Verma, Dr. Ashish Varma, Dr. Amar Taksande, Dr. Somashekhar Nimbalkar, Dr. Utkarsh Sharma, Dr. Vishal Kaushik
Publication Date: 2026/06/08
DOI: 10.59551/DOI: 10.59551/IJHMP/25832069/2026.7.1.130
Abstract
<p>Background: Babies who are born before their time and who need to be admitted in Neonatal Intensive Care Units (NICUs) face many serious problems, both medical and emotional. Family-Centered Care, which we call FCC, is a way of involving the parents directly in the care of the baby. It has shown good results in different parts of the world. But in India, especially in rural and semi-urban hospitals, there are very few good quality randomised trials which have tested this approach properly. This study is trying to find out whether a modified, technology-supported FCC program gives better results as compared to the standard FCC which is already being practiced in our NICU.</p>
<p>Methods: This is a prospective, single-centre, parallel-group randomised controlled trial being done at the NICU of Jawaharlal Nehru Medical College (JNMC) in Wardha, Maharashtra. We will enrol total 88 preterm neonates (born before 37 weeks) whose NICU stay is expected for at least 48 hours, along with their main caregivers. They will be put into two equal groups by computer-based randomisation. The intervention group will receive our modified FCC program, which includes structured parent education sessions, digital counselling through WhatsApp, family rounds conducted by a trained social worker, Kangaroo Mother Care (KMC), and regular meetings between parents and the NICU team. The control group will receive standard FCC as is routinely done. Main outcomes are weight gain of the baby, length of NICU stay, and death during admission. We will also look at family satisfaction, parental stress, breastfeeding rates, and health of baby at one month after discharge.</p>
<p>Discussion: This trial is trying to fill three important gaps which exist in current FCC research: the lack of good quality trial data, the fact that rural Indian settings have been mostly ignored, and the poor use of simple technologies like WhatsApp in NICU care. Whatever results we get will be useful for doctors and policymakers who are thinking about FCC implementation in resource-limited Indian hospitals.</p>
<p>Trial Registration: CTRI (Clinical Trials Registry of India). Ethics approval is obtained from IEC, JNMC, DMIHER, Wardha.</p>
<p><strong>KEYWORDS</strong>: Family-Centered Care, Neonatal Intensive Care Unit, Preterm Neonates, Randomized Controlled Trial, Modified FCC, Parental Satisfaction, Rural India, Study Protocol.</p>
References
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