What is the inspired oxygen fraction that better predicts the need for surfactant administration for the lungs of preterm neonates with neonatal distress syndrome?

Inspired oxygen fraction thresholds accuracy to predict surfactant administration in neonatal RDS is gestational age dependent: a pragmatic, multi-center study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12756197

Enrollment

412

Registered

2023-10-16

Start date

2018-05-01

Completion date

Unknown

Last updated

2023-10-30

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

Conditions

Inspired oxygen fraction as a predictor of need for surfactant in respiratory distress syndrome of preterm neonates Pregnancy and Childbirth

Interventions

This is a secondary analysis of prospectively collected data from 12 NICUs (Università Federico II, Naples

Ospedale Pineta Grande, Castelvolturno

Ospedale Careggi, Università di Firenze, Florence

Ospedale Buzzi, Milan

Università di Milano, Fondazione Policlinico, Milan

Ospedale Salesi, Università Politecnica delle Marche, Ancona

Fondazione Policlinico Gemelli, Roma

Hospital Gregorio Marañón, Madrid

Hospital San Juan de Dio, Barcelona

Hospital Basurto, Bilbao

and, Hospital Puerta del Mar, Cadiz). Two cohorts of preterm infants 250-336 weeks of gestational age (GA) were investigated after validating their homogeneity. Neonates were stratified by gestationa

28-30

31-33 weeks. Written parental consent was obtained and the study was approved by the Ethics Committee “Carlo Romano” at the Università Federico II di Napoli (prot # 1621/17). Formal approval was also

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Premature neonates with respiratory distress syndrome (RDS) enrolled at birth and before the administration of the first surfactant dose. RDS in the preterm infant was defined as the presence of intercostal and subcostal retractions with expiratory grunting shortly after birth in the presence of typical radiographic features.

Exclusion criteria

Exclusion criteria: 1. Infants who were intubated in the delivery room 2. Neonates with major congenital malformations

Design outcomes

Primary

Measure	Time frame
FiO2 thresholds recorded within the first 3 hours of life as predictors of later surfactant administration in preterm neonates by a masked attending physician measured using a secondary analysis of prospectively collected data at one timepoint	—

Secondary

Measure	Time frame
The following secondary outcome measures were measured using prospectively collected data at one timepoint: 1. Gestational age, birth weight, type of delivery, chorioamnionitis, maternal hypertension, PROM, IUGR, Apgar score at 5 min =5, and antenatal steroids recorded within 120 minutes of life 2. First surfactant dose administered (number of infants) 3. Age at first surfactant dose (minutes) 4. FiO2 at first surfactant dose 5. Death or BPD at NICU discharge	—

Measure

Time frame

The following secondary outcome measures were measured using prospectively collected data at one timepoint: 1. Gestational age, birth weight, type of delivery, chorioamnionitis, maternal hypertension, PROM, IUGR, Apgar score at 5 min =5, and antenatal steroids recorded within 120 minutes of life 2. First surfactant dose administered (number of infants) 3. Age at first surfactant dose (minutes) 4. FiO2 at first surfactant dose 5. Death or BPD at NICU discharge

—

Countries

Australia, Italy, Spain

Contacts

Public ContactFrancesco Raimondi

raimondi@unina.it+ 39 0817463268

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026