UMIN-CTR Clinical Trial

Basic information
Public title	Effects of early respiratory physiotherapy techniques on spontaneous respiratory activity of preterm infants: a randomized controlled trial
Acronym	Early Neonatal Respiratory Physiotherapy
Scientific Title	Effects of early respiratory physiotherapy techniques on spontaneous respiratory activity of preterm infants: a randomized controlled trial
Scientific Title:Acronym	Early Neonatal Respiratory Physiotherapy
Region	Europe

Condition
Condition	pretermn infants with respiratory insufficence with/without BPD
Classification by specialty	Pneumology Pediatrics Intensive care medicine Rehabilitation medicine Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of respiratory facilitation physiotherapy technique according to reflex stimulations, applied early to the preterm infant. This intervention is aimed at promoting spontaneous respiratory activity and reducing work of breathing, avoiding or minimizing the use of invasive respiratory support.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of intubation and mechanical ventilation (MV) in the first week of life (excluding the intubation necessary for surfactant administration). This will represent the primary outcome for non-intubated infants in the delivery room.
Key secondary outcomes	- duration of MV during the hospital stay (only for the babies not intubated in the delivery room); - duration of O 2 -therapy during the hospital stay; - development of BPD (O 2 -dependence at 36 weeks of postmenstrual age); - incidence of atelectasis, - duration of non-invasive ventilation (NIV) during the hospital stay; - post-conceptional age attainment of complete respiratory autonomy (absence of any kind of respiratory support and oxygen); - length of the hospital stay - survival.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	In the Study Group the physiotherapist will perform the technique of respiratory facilitation according to the reflex stimulations, experience already conducted in the neonates and modified for the preterm infant. The newborn is placed in supine decubitus and a slight digital pressure is exerted on a hemithorax, more precisely between the 7 th and the 8 th rib (area corresponding to the insertion of the diaphragm muscle) at the level of the mammillary line, pressing from top to bottom (in direction of the support plane) and obliquely (in the direction of the vertebral column). We will define this as a "trigger point". Stimulating the trigger point will stimulate the respiratory activity by determining a compression on the stimulation side with consequent increase of the ipsilateral pulmonary ventilation / minute and the facilitation of the contralateral pulmonary expansion (thoracic expansion of the ribcage). This mechanism will determine the concatenation of input to all anatomical structures in direct and indirect relation to the area being treated, on the basis of the mechanical-neurological-fluidic links of the human body. The above-mentioned maneuver will determine three different consequences at a distance that will positively influence the respiratory dynamics of the preterm infant.The respiratory facilitation technique will be performed for about three minutes and repeated for a total of 4/6 times in sequence: 7th right hemitoraceous space for three minutes, 7th left hemithorax space for three minutes, 7th right space for a further three minutes, 7th left space for a further three minutes. In case of secretions the respiratory facilitation technique will be associated with the prolonged slow expired technique for the preterm infant. This program will be performed 3 times a day until spontaneous respiratory activity is achieved.
Interventions/Control_2	The Control Group Infants will perform exclusively the Individualized Postural Care program.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	24 weeks-old <
Age-upper limit	31 weeks-old >=
Gender	Male and Female
Key inclusion criteria	Preterm newborns with a gestational age less than or equal 30 weeks requiring invasive or non-invasive respiratory support.
Key exclusion criteria	- Outborn - Presence of major congenital malformations and/or genetic syndromes - Fetal hydrops - Inherited disorders of metabolism - Persistent Pulmonary Hypertension of Newborn - Severe circulatory shock (prolonged capillary filling, reduced strength of peripheral pulses, cool skin, lethargy, hypotension, oliguria, increasing lactate concentrations and metabolic acidosis) - Others unstable clinical conditions at the time of randomization for which the newborn can not perform the physiotherapy treatment required by the study.
Target sample size	132

Research contact person
Name of lead principal investigator	1st name Middle name Last name Milena Tana
Organization	Foundation Policlinico University A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy.
Division name	Division of Neonatology
Zip code
Address	Largo A. Gemelli 8, 00168, Rome, Italy
TEL	00393288446775
Email	milenatana@yahoo.it

Public contact
Name of contact person	1st name Middle name Last name Giovanni Vento
Organization	Foundation P. University A. Gemelli IRCCS
Division name	Division of Neonatology
Zip code
Address	Largo A. Gemelli 8, 00168, Rome, Italy
TEL	00390630153237
Homepage URL
Email	giovanni.vento@unicatt.it

Sponsor
Institute	Foundation Policlinico University A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy.
Institute
Department

Funding Source
Organization	Foundation Policlinico University A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy.
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2019 Year 01 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 08 Day
Last follow-up date	2019 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 01 Day
Last modified on	2021 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041084