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Effects of early respiratory physiotherapy techniques on spontaneous respiratory activity of preterm infants: a randomized controlled trial

Effects of early respiratory physiotherapy techniques on spontaneous respiratory activity of preterm infants: a randomized controlled trial - Early Neonatal Respiratory Physiotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036066
Enrollment
132
Registered
2019-09-30
Start date
2018-04-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pretermn infants with respiratory insufficence with/without BPD

Interventions

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 pr
trigger point&quot
. 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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Preterm newborns with a gestational age less than or equal 30 weeks requiring invasive or non-invasive respiratory support.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
- 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.

Countries

Europe

Contacts

Public ContactGiovanni Vento

Foundation P. University A. Gemelli IRCCS Division of Neonatology

giovanni.vento@unicatt.it00390630153237

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026