Newborns smaller than normal who will be randomly and blindly assigned to 21% oxygen or 60% oxygen to be resuscitated to investigate the influence upon mortality and chronic conditions in the neonatal period

Extremely low gestational age neonates randomly an assigned to be blindly resuscitated with 21% vs. 60% oxygen: influence upon mortality and chronic conditions in the neonatal period.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005717-36-ES

Enrollment

304

Registered

2012-03-29

Start date

2012-06-14

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Preterm infants aged 30 weeks or less, who need resuscitation / stabilization maneuvers with positive pressure ventilation immediately after birth

Interventions

Product Name: OXIGENO MEDICINAL LÍQUIDO OXIGEN SALUD, 99,5% gas para inhalación Product Code: OX Pharmaceutical Form: Inhalation gas INN or Proposed INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm infants with gestational age of 30 weeks or less gestation born in tertiary referral centers and needing resuscitation/stabilization maneuvers with positive pressure ventilation immediately after birth Are the trial subjects under 18? yes Number of subjects for this age range: 760 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Uncertainty about gestational age Refusal to participate (parents/guardian) Not fulfilling study protocol Decoding in the delivery room Chromosomopaties Major malformations

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Survival without bronchopulmonary dysplasia (need for oxygen supplementation at 36 weeks post-conceptional age) in preterm infants aged ? 30 weeks gestation.;Timepoint(s) of evaluation of this end point: After birth and at 36 weeks post conceptional age.; Main Objective: To investigate whether intervention consisting in lowering the initial inspiratory fraction of oxygen to 21% as compared to 60% in depressed extremely low gestational age neonates enhances survival without bronchopulmonary dysplasia (need for oxygen supplementation at 36 weeks corrected age). ; Secondary Objective: * Survival with reduced incidence of oxidative stress derived conditions: (i) retinopathy of prematurity (ROP) (ii) persistent ductus arteriosus (PDA) (iii) intra-periventricular hemorrhage and/or leukomalacia (IPVH/LM) (iv) necrotizing enterocolitis (NEC) * Improving neurological outcome measured using the complete Bayley III scale (motor and psychological development) at 24 months postnatal. * Reducing oxidative stress, oxidative damage to cell components and inflammation, DNA repair mechanisms as measured by specific biomarkers in the early postnatal period (<7 days postnatal).	—

Measure

Time frame

Primary end point(s): Survival without bronchopulmonary dysplasia (need for oxygen supplementation at 36 weeks post-conceptional age) in preterm infants aged ? 30 weeks gestation.;Timepoint(s) of evaluation of this end point: After birth and at 36 weeks post conceptional age.; Main Objective: To investigate whether intervention consisting in lowering the initial inspiratory fraction of oxygen to 21% as compared to 60% in depressed extremely low gestational age neonates enhances survival without bronchopulmonary dysplasia (need for oxygen supplementation at 36 weeks corrected age). ; Secondary Objective: * Survival with reduced incidence of oxidative stress derived conditions: (i) retinopathy of prematurity (ROP) (ii) persistent ductus arteriosus (PDA) (iii) intra-periventricular hemorrhage and/or leukomalacia (IPVH/LM) (iv) necrotizing enterocolitis (NEC) * Improving neurological outcome measured using the complete Bayley III scale (motor and psychological development) at 24 months postnatal. * Reducing oxidative stress, oxidative damage to cell components and inflammation, DNA repair mechanisms as measured by specific biomarkers in the early postnatal period (<7 days postnatal).

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Secondary

Measure	Time frame
Secondary end point(s): * Survival with reduced incidence of oxidative stress derived conditions: (i) retinopathy of prematurity (ROP) grades 2 and 3 as defined by ETROP a. If in zone I: Stage 3 ROP, even without plus disease b. Plus disease with any stage ROP c. If in zone II: Plus disease with stage 2 ROP d. Plus disease with stage 3 ROP e. Any need for retinal surgery or the administration of avastin significant flow). (ii) intra-periventricular hemorrhage and/or leukomalacia (IPVH/LM) as detected by cranial ultrasonography (Papile LA et al J Pediatr 1983) (iii) necrotizing enterocolitis (NEC) (Bell?s classification Bell MJ Pediatr Clin N Amer 1985. * Time of oxygen supplementation needed (days) * Time of mechanical ventilation needed including CPAP (days) * Doses of surfactant needed (n) * Incidence of air leaks (%) * Improved neurological outcome determined by Bayley III scale (motor and psychological development) at 24 months postnatal. * Reducing oxidative stress, oxidative damage to cell components and inflammation as measured by specific biomarkers in the early postnatal period (<7 days postnatal): (i) Reduced (GSH) and oxidized (GSSG) glutathione ratio (Mass Spectrometry) (ii) Interleukin 8 (ELISA) (iii) TNF? (ELISA) (iv) Ortho-tyrosine / Phenylalanine ratio (HPLC coupled to MS/MS) (v) 8-hydroxy-2-deoxyguanosine / 2 deoxyguanosine ratio (HPLC coupled to MS/MS) (vi) Isoprostanes and Isofurans (Gas chromatography coupled to MS/MS) (vii) Targeted and Untargetted metabolomics (viii) DNA repair mechanisms (ix) Proteomics ;Timepoint(s) of evaluation of this end point: See above (E.5.2)	—

Measure

Time frame

Secondary end point(s): * Survival with reduced incidence of oxidative stress derived conditions: (i) retinopathy of prematurity (ROP) grades 2 and 3 as defined by ETROP a. If in zone I: Stage 3 ROP, even without plus disease b. Plus disease with any stage ROP c. If in zone II: Plus disease with stage 2 ROP d. Plus disease with stage 3 ROP e. Any need for retinal surgery or the administration of avastin significant flow). (ii) intra-periventricular hemorrhage and/or leukomalacia (IPVH/LM) as detected by cranial ultrasonography (Papile LA et al J Pediatr 1983) (iii) necrotizing enterocolitis (NEC) (Bell?s classification Bell MJ Pediatr Clin N Amer 1985. * Time of oxygen supplementation needed (days) * Time of mechanical ventilation needed including CPAP (days) * Doses of surfactant needed (n) * Incidence of air leaks (%) * Improved neurological outcome determined by Bayley III scale (motor and psychological development) at 24 months postnatal. * Reducing oxidative stress, oxidative damage to cell components and inflammation as measured by specific biomarkers in the early postnatal period (<7 days postnatal): (i) Reduced (GSH) and oxidized (GSSG) glutathione ratio (Mass Spectrometry) (ii) Interleukin 8 (ELISA) (iii) TNF? (ELISA) (iv) Ortho-tyrosine / Phenylalanine ratio (HPLC coupled to MS/MS) (v) 8-hydroxy-2-deoxyguanosine / 2 deoxyguanosine ratio (HPLC coupled to MS/MS) (vi) Isoprostanes and Isofurans (Gas chromatography coupled to MS/MS) (vii) Targeted and Untargetted metabolomics (viii) DNA repair mechanisms (ix) Proteomics ;Timepoint(s) of evaluation of this end point: See above (E.5.2)

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Countries

Spain

Contacts

Public ContactUREC

Instituto de Investigacion Sanitaria La Fe

investigacion_clinica@iislafe.es34961973313

Outcome results

None listed

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