Effects of early respiratory physiotherapy on spontaneous respiratory activity of preterm infants: study protocol for a randomized controlled trial

Abstract

Background Tactile maneuvers stimulating spontaneous respiratory activity in preterm infants are recommended since birth, but data on how and how often these maneuvers are applied in clinical practice are unknown. In the last years, most preterm newborns with respiratory failure are preferentially managed with non-invasive respiratory support and by stimulating spontaneous respiratory activity from the delivery room and in neonatal intensive care unit (NICU), in order to avoid the risks of intubation and prolonged mechanical ventilation. Methods Preterm infants with gestational age < 31 weeks not intubated in the delivery room and requiring non-invasive respiratory support at birth will be eligible for the study. They will be randomized and allocated to one of two treatment groups: (1) the study group infants will be subject to the technique of respiratory facilitation within the first 24 h of life, according to the reflex stimulations, by the physiotherapist. The newborn is placed in supine decubitus and a slight digital pressure is exerted on a hemithorax. The respiratory facilitation technique will be performed for about three minutes and repeated for a total of 4/6 times in sequence, three times a day until spontaneous respiratory activity is achieved; thus, no respiratory support is required; (2) the control group infants will take part exclusively in the individualized postural care program. They will perform the technique of respiratory facilitation and autogenous drainage. Objective To evaluate the efficacy of early respiratory physiotherapy in reducing the incidence of intubation and mechanical ventilation in the first week of life (primary outcome). Discussion The technique of respiratory facilitation is based on reflex stimulations, applied early to preterm infant. Slight digital pressure is exerted on a “trigger point” of each hemithorax, to stimulate the respiratory activity with subsequent increase of the ipsilateral pulmonary minute ventilation and to facilitate the contralateral pulmonary expansion. This mechanism will determine the concatenation of input to all anatomical structures in relation to the area being treated, to promote spontaneous respiratory activity and reducing work of breathing, avoiding or minimizing the use of invasive respiratory support. Trial registration UMIN-CTR Clinical Trial UMIN000036066. Registered on March 1, 2019. Protocol 1. https://www.umin.ac.jp/ctr

Early Respiratory Physiotherapy versus an Individualized Postural Care Program for Reducing Mechanical Ventilation in Preterm Infants: A Randomised Controlled Trial

“…Preterm infants who met the eligibility criteria were randomly divided into two groups during the first 24 h of life [6].…”

“…Ralloc, a Stata/IC 15.1 for Windows (Stata-Corp, College Station, TX, USA), was used to create a sequence of treatments that were randomly permuted into blocks of varying size and order. Concealment of allocation was ensured by sequentially numbered, opaque, sealed envelopes [6].…”

“…The indications for MV were poor oxygenation with FiO 2 greater than 0.40 after rescue surfactant, respiratory acidosis (pCO 2 > 65 mm Hg [8.5 kPa] and pH < 7.20), or apnoea (more than four episodes of apnoea per hour or more than two episodes of apnoea per hour requiring ventilation with bag and mask), despite optimal non-invasive respiratory support (nasal CPAP, nasal intermittent positive pressure ventilation, or bilevel positive airway pressure) [6].…”

“…Written and oral information was offered to parents if their infant was likely to be eligible. Informed written consent was obtained from both parents and sufficient time was provided for consent [6].…”