Abstract
BackgroundTactile 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.MethodsPreterm 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.ObjectiveTo evaluate the efficacy of early respiratory physiotherapy in reducing the incidence of intubation and mechanical ventilation in the first week of life (primary outcome).DiscussionThe 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 registrationUMIN-CTR Clinical Trial UMIN000036066. Registered on March 1, 2019. Protocol 1. https://www.umin.ac.jp/ctr
Highlights
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
The technique of respiratory facilitation is based on reflex stimulations, applied early to preterm infant
In the last years, most preterm newborns with respiratory failure are preferentially managed with non-invasive respiratory support and by stimulating spontaneous respiratory activity just after birth in both the delivery room and neonatal intensive care unit (NICU), in order to avoid the risks of intubation and mechanical ventilation
Summary
The primary hypothesis of this study is a reduction in the need of mechanical ventilation (MV) in the first week of life (excluding the transient tracheal intubation performed for surfactant administration) in spontaneously breathing infants born at 24+0–30+6 weeks’ gestation receiving a respiratory facilitation maneuver according to the reflex stimulations compared to exclusive standard individualized postural care program. The control group infants will perform exclusively the individualized postural care program They will perform the technique of respiratory facilitation and autogenous drainage modified only in the presence of clinically and radiographically established pulmonary atelectasis. The intervention in the study group will be continued in case of intubation and start of MV during the entire hospital stay, to enhance respiratory function and favoring extubation Infants of both groups will receive 200 mg/kg of poractant alfa (Chiesi Farmaceutici, Parma, Italy) if they will need FiO2 ≥ 0.30 and CPAP of 6–7 cm H2O, by INSUR-E technique (if gestational age ≥ 28 weeks) or INREC-SUR-E technique [20] (if gestational age < 28 weeks), as per our NICU protocol.
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