Outcome for Extremely Premature Infants A 400 ‐ Gram Female Infant Delivered at 24 and 4/7 Weeks. Andrew T. Costarino, M.D. SPA October 2013 SPA October 2013 Photo: N Engl J Med 2013;368:2349 ‐ 2351 .
• Preterm: Birth prior to: P t Bi th i t – 37 completed weeks of gestation – or fewer than 259 days since the first day of a f th 259 d i th fi t d f woman’s last menstrual period. • Sub ‐ divided on gestational age: • Sub ‐ divided on gestational age: • Late preterm (34 to <37 weeks) • Moderate preterm (32 to <34 weeks) Moderate preterm (32 to <34 weeks) • Very preterm (28 to <32 weeks) • Extremely preterm (<28 weeks) Extremely preterm (<28 weeks) W World Health Organization: 1977 ld H lth O i ti 1977
Preterm Birth USA, 2011 Total Births ‐ 3,953,590 Total Births 3 953 590 Total Preterm Births ‐ 463,756 Preterm Birth Rate – 11.73% Associated Infant Deaths – 10,991 495,000 440,000 440 000 34 ‐ 36 wks 8.28% (327,357) 385,000 330,000 32 ‐ 33 wks 1.52% (60,095) 275 000 275,000 220,000 28 ‐ 31 wks 1.2% (47,443) 165,000 110,000 <28 wks .73% (28,861) 55,000 0 Preterm CDC, National Center for Health Statistics Final Data 2011
Preterm Birth USA Preterm Birth Rate 2012: 11 5% Preterm Birth Rate 2012: 11.5%
Twin and triplet birth rates: USA, 1980–2010 Hamilton BE et al. Pediatrics 2013;131:548 ‐ 558
VLBW Outcomes of the NICHD Neonatal Network Survival by GA 100 90 90 80 val (%) 70 60 50 50 Surviv 40 30 20 10 0 Gestational Age Hack M et al. Pediatrics 1991;87: 587 ‐ 597
ELBW Infants Outcome Innovation Time CPAP, MV techniques 1980’s Exogenous Surfactant Early 1990’s Antenatal Steroids Mid/Late 1990’s Avoiding Postnatal Steroids Early 2000’s Targeted Oxygen Therapy Mid 2000’s Systematic Care/Experience Continuous
Outcome Studies ELBW Infants Country Country Year Year Sponsor Sponsor 1 USA 1987 NICHD 2 USA 1992 NICHD 3 Australia 1992 Victoria Collaborative Study Group 4 Belgium 1992 EPIBEL Study Group 5 UK/Ireland 1995 EPIcure Study Collaborative 6 France 1997 EPIPAGE Study Group 7 USA 2003 Vermont Oxford 8 USA 2004 NICHD 9 Australia 2005 Victoria Collaborative Study Group 10 10 Belgium Belgium 2005 2005 EPIBEL Study Group EPIBEL Study Group 11 Japan 2005 Japanese Neonatal Network
ELBW Infants Survival 100 80 26 weeks 25 weeks 60 cent 24 weeks Perc 23 weeks 40 22 weeks 20 0 0 0 1 2 3 4 5 6 7
ELBW Infants Survival 100 80 26 weeks 25 weeks 60 cent 24 weeks Perc 23 weeks 40 22 weeks 20 0 0 0 1 2 3 4 5 6 7
ELBW Morbidity ELBW Morbidity Risk Risk 95% CI 95% CI Acute/NICU Acute/NICU Any ROP Severe ROP Severe ROP IVH (Grade III ‐ IV) Surgical NEC g Chronic Problems BPD (O2 at 36 weeks) BPD (clinical) Blindness Hearing loss Cerebral Palsy Cognitive Delay
Cross KW. Lancet 1973;ii:954 ‐ 956
ELBW Oxygen Trials • USA: “SUPPORT” N=1316 – NEJM 2010;362:1959 NEJM 2010;362:1959. – NEJM 2012;367:2995. • Canada/Europe: “COT” N=1201 • Canada/Europe: COT N=1201 – JAMA. 2013;309:2111. • UK/Australia/NZ: “BOOST” N=2448 • UK/Australia/NZ: “BOOST” N=2448 – NEJM 2013;368: 2094 ‐ 2104
ELBW Morbidity ELBW Morbidity Risk Risk 95% CI 95% CI Acute/NICU Acute/NICU 63.7 60.6 – 66.6 Any ROP 12.3 11.3 – 13.3 Severe ROP Severe ROP 14.1 13.1 – 15.2 IVH (Grade III ‐ IV) 10.1 9.3 – 11.0 Surgical NEC g Chronic Problems 42.2 40.4 – 43.9 BPD (O2 at 36 weeks) 38.7 36.9 – 40.5 BPD (clinical) 0.8 0.36 – 1.62 Blindness 3.1 2.1 – 4.4 Hearing loss 6.1 4.7 – 7.7 Cerebral Palsy 7.4 5.2 – 9.4 Cognitive Delay
ELBW Morbidity: Neurodevelopmental • Domains of Neurodevelopmental disabilities Domains of Neurodevelopmental disabilities. – Motor (cerebral palsy) • Gross motor G • Fine motor – Cognition – Speech and language Speech and language, – Personal ‐ social – Activities of daily living. A i i i f d il li i
ELBW Morbidity: Cerebral Palsy Cerebral Palsy A non ‐ progressive motor disability due to damage to the A i di bili d d h • motor control centers of the developing brain. Damage can occur during gestation, at birth or after birth D d i t ti t bi th ft bi th • up to about 3 years of age. Affects about 2 5/1 000 children in the US Affects about 2.5/1,000 children in the US. • • Prematurely born infants are at increased risk for CP. • Close to half of children with CP were born prematurely. • Often used as a marker for over ‐ all neurologic outcomes • associated with prematur ity.
Risk of Cerebral Palsy Risk of Cerebral Palsy Pooled Risk Estimate 10.4 95% CI: 7.3 – 13.5 45 40 urvivors 35 30 cent of su 25 20 15 Perc 10 5 0
ELBW Morbidity Reid SM et al. Dev Med Child Neurol 2011; 53:907 ‐ 912.
ELBW Morbidity ELBW Morbidity Risk Risk 95% CI 95% CI Acute/NICU Acute/NICU 63.7 60.6 – 66.6 Any ROP 12.3 11.3 – 13.3 Severe ROP Severe ROP 14.1 13.1 – 15.2 IVH (Grade III ‐ IV) 10.1 9.3 – 11.0 Surgical NEC g Chronic Problems 42.2 40.4 – 43.9 BPD (O2 at 36 weeks) 38.7 36.9 – 40.5 BPD (clinical) 0.8 0.36 – 1.62 Blindness 3.1 2.1 – 4.4 Hearing loss 6.1 4.7 – 7.7 Cerebral Palsy 7.4 5.2 – 9.4 Cognitive Delay
Logistic regression: O Outcome: mod/severe CP d/ CP Risk factors: PVL Grade 3 ‐ 4 IVH BPD Postnatal Steroids Postnatal Steroids Male Gender Vohr BR et al. Pediatrics 2005;116:635 ‐ 643
ELBW Morbidity: Cognitive Delay ELBW Morbidity: Cognitive Delay • Bayley Scales of Infant Development, (designed for children aged 0 to 3 years) to 3 years). • The first developed in the 1960’s • Behavioral/play examination raw score converted to composite • Behavioral/play examination ‐ raw score converted to composite scale then referenced to normative values. • The scores have a normal distribution with a mean of 100 and The scores have a normal distribution with a mean of 00 and standard deviation of 16. • Revised and in 1993 = Bayley II comprised of 2 parts: – MDI (Mental Developmental Index) cognitive and language – PDI (Psychomotor Developmental Index) motor skills. ( y p )
Bayley Developmental Index in Premature Survivors 120 SD) Advanced Development (Green dash) 110 110 ex (mean± 100 Normal (Pink shaded) mental Inde 90 Developm 80 Significantly Delayed Development (Red dash) 70 60 Period I Period II Hack M. et al. Pediatrics 1996; 98: 931 ‐ 937
Cognitive Impairment Moore T et al. Brit Med J. 2012;345:e7961
ELBW Morbidity: Cognitive Delay Pooled Risk Estimate 25.2, 95% CI: 20.4 – 30.5 80 70 60 50 Percent 40 P 30 20 10 10 0
Logistic regression for MDI <70, ORs and 95% CIs. Logistic regression Logistic regression Outcome: cognitive delay Risk factors: PVL Grade 3 ‐ 4 IVH Early 90’s EPOCH y Postnatal Steroids Male Gender Vohr BR et al. Pediatrics 2005;116:635 ‐ 643
ELBW Morbidity ELBW Morbidity Risk Risk 95% CI 95% CI Acute/NICU Acute/NICU 63.7 60.6 – 66.6 Any ROP 12.3 11.3 – 13.3 Severe ROP Severe ROP 14.1 13.1 – 15.2 IVH (Grade III ‐ IV) 10.1 9.3 – 11.0 Surgical NEC g Chronic Problems 42.2 40.4 – 43.9 BPD (O2 at 36 weeks) 38.7 36.9 – 40.5 BPD (clinical) 0.8 0.36 – 1.62 Blindness 3.1 2.1 – 4.4 Hearing loss 6.1 4.7 – 7.7 Cerebral Palsy 7.4 5.2 – 9.4 Cognitive Delay
ELBW Morbidity ELBW Morbidity Risk Risk 95% CI 95% CI Acute/NICU Acute/NICU 63.7 60.6 – 66.6 Any ROP 12.3 11.3 – 13.3 Severe ROP Severe ROP 14.1 13.1 – 15.2 IVH (Grade III ‐ IV) 10.1 9.3 – 11.0 Surgical NEC g Chronic Problems 42.2 40.4 – 43.9 BPD (O2 at 36 weeks) 38.7 36.9 – 40.5 BPD (clinical) 0.8 0.36 – 1.62 Blindness 3.1 2.1 – 4.4 Hearing loss 6.1 4.7 – 7.7 Cerebral Palsy 7.4 5.2 – 9.4 Cognitive Delay
Short ‐ term outcome at discharge for infants with a GA of 24 to 26 wks Vanhaesebrouck P et al. Pediatrics 2004;114:663 ‐ 675
Died Died Severe Disability 27 Disability 40 No disability 12 Gestational Age Gestational Age 12 Birth weight Anenatal Steroids Gender Multiple/Singleton Gestation Tyson JE et al. N Engl J Med 2008; 358:1672 ‐ 168
http:// www nichd nih gov /about/org/der/branches/ppb http:// www.nichd.nih.gov /about/org/der/branches/ppb /programs/epbo/pages/epbo_case.aspx
ELBW Outcome ELBW Outcome • Premature birth significant cause of infant mortality and child morbidity • US Premature birth rate decreasing now 11.5% • Viability (50% survival) in developed countries = 23 ‐ 24 wks GA • The smallest infants are at significant risk of death and disability – 30 ‐ 50% Mortality % li – Survivors 40 ‐ 80% significant morbidity
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