Alessia Di Polito1, Arianna Del Vecchio1, Milena Tana2, Patrizia Papacci3, Anna Laura Vento1, Benedetta Campagnola1, Sefora Celona1, Laura Cricenti1, Ilaria Bastoni1, Chiara Tirone2, Alessandra Lio2, Claudia Aurilia2, Anthea Bottoni2, Angela Paladini2, Francesco Cota2, Paola Emilia Ferrara1, Gianpaolo Ronconi1, Giovanni Vento4. 1. Servizio Medicina Fisica e Riabilitazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. 2. Dipartimento Scienze della salute della donna, del bambino e di sanità pubblica, Unità Operativa Complessa di Neonatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. 3. Dipartimento Universitario Scienze della Vita e Sanità Pubblica. Unità Operativa Complessa di Neonatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy. 4. Dipartimento Universitario Scienze della Vita e Sanità Pubblica. Unità Operativa Complessa di Neonatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy. giovanni.vento@unicatt.it.
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.
RCT Entities:
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.
Authors: Victoria Dumont; Jan Bulla; Nicolas Bessot; Julie Gonidec; Marc Zabalia; Bernard Guillois; Nadège Roche-Labarbe Journal: Dev Psychobiol Date: 2017-07 Impact factor: 3.038
Authors: Kristel Kuypers; Tessa Martherus; Tereza Lamberska; Janneke Dekker; Stuart B Hooper; Arjan B Te Pas Journal: Arch Dis Child Fetal Neonatal Ed Date: 2020-04-29 Impact factor: 5.747