A study of supine Vs. Prone positioning on responses of preterm infants on ventilator support - A randomized controlled trial protocol

Background: Preterm infants spend a considerable amount of time in the Neonatal Intensive Care Unit (NICU)braving the overwhelming stimuli. The sick preterm infants are usually put on ventilator support for their respiratory problems. Ventilation is usually invasive and extremely stressful for these infants. Preterm infants, on ventilation especially on mechanical ventilation may manifest physiological instability. Disorganized sleep states, disruption of the behavioral states/organization and stress may also result in response to the external stimuli exerted due to use of ventilation. Proper positioning may help in providing the necessary supportive care required for these infants. Methodology: A randomized trial using crossover design will be conducted. A sample size of 30 preterm infants who are admitted to the NICU and who are placed on mechanical ventilation will be assessed for eligibility to be included in the study. The parent(s) of the preterm infants will be approached for informed proxy consent. To achieve an equal distribution of prone-then-supine (P-S) and the supinethen- prone (S-P) position sequence, permuted block randomization will be performed. After the preterm infants are recruited to the study, a study assistant, not involved in the outcome assessment will allocate the preterm infant(s) to either the supine or prone positions after the opening a sealed opaque envelope having the allocation sequence. Outcome measures (behavioral states/organization and stress responses) will be assessed at the baseline i.e., before providing a particular position, during the entire period of supine positioning and during the entire period of prone positioning.