Title of the Study :
Comparison of Proprioceptive Nest with standard nesting to meet the proprioceptive needs of preterm neonates in the NICU: A randomized control, non-inferiority study.
Introduction/Rationale
Proprioceptive stimulation is an integral part of neurodevelopment from the fetal period. When the fetus moves in the uterus, that movement generates proprioceptive feedback. These intrauterine movements also aid in improving bone formation and mineralization. In a preterm infant admitted to the NICU, all these proprioceptive stimulation and stimulation for bone formation get compromised in the less favorable extrauterine environment. This may contribute to metabolic bone disease in preterm infants, including those from tribal populations. An inventive nesting device called Proprioceptive Nest was designed to give preterm infants comfort and age-appropriate proprioceptive stimulation. CTRI/2024/09/074276.
Objectives
To compare the efficacy of the newly designed device with standard nesting practice in preterm neonates < 36 weeks admitted to the NICU.
Methodology
Open-label, parallel-group, randomized controlled trial with 1:1 allocation ratio. Level 3 NICU. All preterm neonates > 28 weeks gestation that are admitted to the NICU
Results
A total of 60 eligible patients were enrolled. The control group's average weight was 1401.27 grams, while the experimental group's was 1321.11 grams. The average stay lasted 24 days. At Day 21 of life, the experimental group's patients had a blood ALP level was controlled. Evaluation using the Hammersmith Neonatal Neurological Examination (HNNE) at discharge revealed a modest improvement in the experimental group's Optimality Score.
Conclusion
The Proprioceptive Nest was non-inferior to the standard nest in terms of impact on neurodevelopment and urine calcium, blood phosphorus, and alkaline phosphatase levels in preterm neonates. Additionally, Proprioceptive Nest provided good positional support, increased oral feed and weight, neurobehavioral organization, and better quality of sleep. For the at-risk preterm babies, this simple non-invasive measure might be seen as a community-level intervention for every newborn.