UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

09

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2019

Year

03

Month

01

Day

Last modified on

2021

Year

03

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041084