Heather L. Brumberg MD, MPH Comparison of Utilization of Interventional Therapies Between Moderately Preterm and Very Preterm Infants at 12 Months Corrected Age Jessica L. Kalia DO Paul Visintainer PhD Heather L. Brumberg MD, MPH Maria Pici MD Jordan Kase MD

Background In the last two decades, the prematurity rate has risen by more than 30% A classification system of premature babies¹ Preterm <37 weeks gestation Late preterm 34-36 weeks gestation Moderately preterm 32-36 weeks gestation Very preterm < 32 weeks gestation In the last 2 decades, the rate of prematurity has risen by more than 30%. Premature birth has been classified into several gestational age categories. Preterm infants are those born at less than 37 weeks. Late preterms are 34-36 weeks. Moderately preterms are born at 32-36 weeks and very preterms have completed less than 32 weeks of gestation. ¹Mathews TJ et al. Natl Vital Stat Rep 2004

Moderately Preterm Moderately preterm infants (32-36 weeks gestation) comprise over 80% of preterm births and are the fastest growing subgroup of preterm infants² Their morbidity rates are higher than term infants Brain weight at 34 weeks is only 65% of the brain weight of full term babies³ Few data are published addressing their developmental outcomes and follow up needs With prematurity is on the rise, it has been shown that moderately preterm infants, those 32-36 weeks gestation, comprise over 80% of all preterm births. They are the fastest growing subgroup of preterm infants. Their morbidity rates are higher than term infants. Interestingly, their brain weight at 34 weeks is only 65% of the brain weight of full term babies. Few data are published addressing their developmental outcomes and follow up needs. In our study, we looked at the use of Early intervention as one of the ways to assess the developmental needs of these babies. ²Davidoff MJ et al. Semin Perinatol 2006 ³Guihard-Costa AM et al. Early Hum Dev 1990

Early Intervention Early Intervention (EI) was created by Congress in 1986 under the Individuals with Disabilities Education Act (IDEA) To be eligible for services a child must be < 3 years old with one of the following: 12 month delay in 1 functional area 33% delay in 1 functional area 25% delay in each of 2 areas (physical, cognitive, communication, social-emotional, adaptive) In 1986 Congress created Early Intervention under the Individuals with Disabilities Education Act. A child is eligible for services if he or she is less than 3 yo and has either a 12 mo delay in 1 functional area, a 33% delay in 1 functional area, or a 25% delay in 2 major developmental areas- physical, cognitive, communication, social-emotional, or adaptive. There are several ways for a child to be referred to EI- a parent or any health care provider can make the referral. In addition, any baby born with a birth weight less than 1000 grams is automatically referred for evaluation.

Objective Compare the enrollment in EI and the utilization of therapeutic services between moderately preterm (32-36 weeks gestation) and very preterm (<32 weeks gestation) infants at 12 months ± 2 months corrected age The goal of our study was to compare at 12 mo ± 2mo corrected age, the enrollment in EI and the utilization of therapeutic services between moderately preterm and very preterm infants. We targeted enrollment in EI because in order for a child to qualify for this service, there must be at least a 33% developmental delay. This is an objective measurement that can be translated across examiners and developmental testing methods. It is important to understand that we looked at enrollment in EI not just babies who were referred for evaluation.

Methods Preterm infants followed at the Regional Neonatal Follow-up Clinic in White Plains, NY from Jan 2005 through Oct 2006 Included all patients <37 weeks gestation who had an evaluation at 12 months ± 2 months corrected age (CA) Stratified into moderately preterm (32-36 weeks gestation) and very preterm (<32 weeks gestation) groups Antenatal, maternal, and neonatal variables obtained by NICU discharge summaries and parental report In this retrospective study, our cohort of infants were preterm infants followed at the regional neonatal follow up clinic in White Plains, NY from Jan 2005 to Oct 2006. All preterms who had an evaluation at the follow up clinic at 12 mo ± 2mo corrected age were included and then stratified into moderately preterm and very preterm groups. We analyzed antenatal, maternal, and neonatal variables obtained by parental report and NICU discharge summaries.

Methods Logistic regression used to compare moderately preterm to very preterm enrollment into early intervention (EI), physical therapy (PT), occupational therapy (OT), speech therapy (ST), and special education, controlling for antenatal, sociodemographic, and neonatal factors Chi square and Fisher’s exact tests were used to compare characteristics of the very preterm (VP) and moderately preterm (MP) infants with significance of p<0.05 A logistic regression model was used to compare moderately preterm to very preterm enrollment into EI, PT, OT, speech therapy and special education. We controlled for antenatal, sociodemographic and neonatal factors in the analysis. Chi square and Fisher’s exact tests were used to compare characteristics of the very preterm and moderately preterm infants.

Results Our dataset contained 497 preterm infants, of which 169 met our inclusion criteria. Of those, 77 were very preterm and 92 were moderately preterm. 208 babies were not yet 12 mo +/- 2 mo corrected age at the time of the study. 20% of the preterm babies were lost to follow up. 19 did not have an examination at the clinic during the time window we were studying. Over 65% of the patients we studied were born at Westchester Medical Center. The remainder were born in hospitals throughout the lower Hudson Valley region.

Patient Characteristics Moderately Preterm Very Preterm p value Gestational age (weeks) # 34 ± 1 28 ± 2 <0.001 Birth wt (grams) # 2124 ± 493 1114 ± 374 Length of stay (weeks) # 2.3 ± 2.0 8.9 ± 5.4 5 min Apgar ^ 9 (6,9) 7 (1,9) Sex, n (%) NS Male 55 (60) 37 (48) Female 37 (40) 40 (52) Delivery type, n (%) NSVD 27 (32) 20 (26) C/S 40 (48) 39 (51) Stat C/S 17 (20) 18 (23) We looked at various antenatal and neonatal characteristics of the babies included in our study. The very preterm and moderately preterm babies were significantly different from each other in obvious ways such as mean GA , birthweight, length of stay, and 5 minute Apgar score. # mean ± SD , ^median (min,max), NS = not significant

Patient Demographics Moderately Preterm Very Preterm p value Multiple gestation, n (%) 0.02 Singleton 62 (67) 60 (78) Twins 21 (22) 17 (22) Triplets 9 (10) 0 (0) Medicaid, n (%) 80 (87) 71(92) NS Maternal age (years) # 31 ± 7 29 ± 7 Maternal race, n (%) 0.01 Caucasian 34 (38) 14 (18) African American 20 (22) 21 (28) Hispanic 30 (33) 26 (34) Other 6 (7) 15 (20) Maternal substance abuse, n (%) 8 (9) 7 (9) Multiple gestation differs between the moderately preterm and very preterm groups due to the 9 triplets in the moderately preterm group. There are also racial differences between the two groups. # mean ± SD , NS = not significant

Patient Co-Morbidities Moderately Preterm Very p value BPD, n (%) 0 (0) 18 (23) <0.001 Caffeine, n (%) 10 ( 11) 60 (79) Genetic disorder, n(%) 2 (2) 1 (1) NS Hydrocephalus, n (%) 3 (3) 4 (5) NEC, n (%) 5 (6) 0.020 RDS, n (%) 33 (36) 70 (91) Congenital heart disease, n (%) 2 (3) Neurologic disorder, n (%) 7 (8) 6 (8) PVL, n (%) ROP, n (%) 7 (9) 0.003 IVH Grade ≥ III, n (%) 4 (6) We also looked at the morbidities in these infants. BPD, caffeine for apnea of prematurity, NEC, RDS, and ROP reached statistical significance between the two groups. This may be due to very preterm infants being more likely to have these morbidities than moderately preterm babies. NS = not significant

Rate of Therapy Use * * * * * p= <0.05 * From this data, we can see that 36% of MP used EI, 28% used PT, 17% OT, 16% ST and 8% special education. This is a substantial number of services needed by babies considered to be “near” term. We also may be underestimating their use of speech therapy and special education as these services are usually started after 12 months of age. * p= <0.05

Very Preterm vs. Moderately Preterm Odds Ratios EI PT OT Speech * Special Ed When we looked at the unadjusted odds ratios comparing the use of therapies in very preterms to moderately preterms, not surprisingly we found that very preterm infants were more likely to utilize EI, PT, OT, speech therapy and special education. 1 10

Very Preterm vs. Moderately Preterm Adjusted Odds Ratios EI Adjusted for: 5 minute Apgar score Caffeine BPD RDS Length of stay PT OT Speech However, when we adjusted for the neonatal characteristics that were significantly different between the moderately preterm and very preterm infants- the 5 minute Apgar score, caffeine for apnea of prematurity, BPD, RDS, and length of stay there was no significant difference between the likelihood of very preterms and moderately preterms to use EI, PT, OT, speech tx and special education. Perhaps extrauterine brain growth is different than intrauterine, and any degree of prematurity, even moderate prematurity may put babies are at risk for developmental delays. Special Ed 1 10

Summary Over 1/3 of moderately preterm infants were enrolled in EI and 28% received physical therapy When adjusting the odds ratios for neonatal factors, there was no difference in the odds of utilizing therapies between the two gestational age groups We conclude that in our cohort of infants, over 1/3 of the moderately preterm infants were enrolled in EI and 28% received PT. When we adjusted for factors such as the 5 minute Apgar score, caffeine for apnea of prematurity, BPD, RDS and length of stay, there was no difference in the odds of utilizing therapies between moderately preterm and very preterm infants.

Conclusion Moderately preterm babies are at risk and must be screened and referred for interventional therapies They should not be considered “small” full term infants Therefore we conclude that moderately preterm babies are at risk for developmental delay and must be screened and referred for interventional therapies. We should not treat them as small full term infants.

Implications If our results could be extrapolated to the general population, there would be 150,000 moderately preterm and 75,000 very preterm infants enrolled in EI per year We speculate that if our results could be extrapolated to the general population, being that there are almost 4.2 million births per year and a 12.5% prematurity rate, there would be 150,000 moderate preterms and 75,000 very preterm infants enrolled in early intervention each year. Quite a few moderately preterm infants! Future studies need to be done on this rapidly growing group of moderately preterm infants. Prospective and longitudinal studies could be done to show developmental, behavioral, cognitive, psychomotor and medical outcomes of these at risk infants. Thank you.

Acknowlegements Westchester Medical Center Jordan Kase MD Heather Brumberg MD, MPH Sergio Golombek MD, MPH Dept of Epidemiology, NY Medical College Paul Visintainer PhD Children’s Rehabilitation Center Maria Pici MD

Back up slides

Moderately Preterm Services Utilized Gestational Age Early Intervention n (%) Physical Therapy 32 weeks 7 (44) 4 (25) 33 weeks 6 (30) 3 (15) 34 weeks 6 (19) 35 weeks 6 (40) 36 weeks 8 (80) 7 (70)

Hospital of Birth Bon Secours 0.6% Phelps Memorial Horton Hospital 3.0% Putnam Hospital 4.2% Hudson Valley 1.8% Sound Shore 12.4% Lawrence Hospital St. Anthony’s Nyack Hospital 1.2% St. John’s Riverside Our Lady of Mercy 2.4% St. Luke’s Westchester Medical Center 66.9%

Excluded patients 328 babies not evaluated 19 babies with no assessment at 12 months ± 2 months corrected age 208 babies were not yet 12 months ± 2 months corrected age at time of study 101 babies lost to follow-up (20%)

Characteristics of moderately preterm infants Excluded Moderate Preterms Included p value Gestational age (weeks) * 34 ± 1 0.71 Birth wt (grams)* 2152 ± 465 2124 ± 492 0.65 Length of stay (weeks)* 2.6 ± 4.3 2.3 ± 2.0 0.34 Sex, n (%) 0.44 male 104 (54) 55 (60) female 88 (45) 37 (40) Delivery type, n (%) 0.45 nsvd 73 (39) 27 (32) c/s 84 (45) 40 (47) stat c/s 29 (16) 17 (20) * Mean ± SD

Characteristics of moderately preterm infants Excluded moderately preterm Included moderately preterm p value Multiple gestation, n (%) 0.002 singleton 147 (77) 62 (67) twins 42 (22) 21 (22) triplets 2 (1) 9 (10) Medicaid, n (%) 123 (64) 80 (86) <0.001 Maternal age (years) 30 ± 6 31 ± 7 0.808 Maternal race, n (%) 0.448 Caucasian 81 (44) 35 (39) African American 28 (15) 21 (23) Hispanic 59 (32) 30 (33) Other 17 (9) 4 (4) Maternal substance abuse, n (%) 11 (6) 8 (8) 0.446

Characteristics of moderately preterm infants Excluded Moderately Preterm Included p value BPD, n (%) 1 (53) 0 (0) 0.675 Caffeine, n (%) 19 (10) 10 (11) 0.833 Genetic disorder, n (%) 7 (4) 2 (2) 0.723 Hydrocephalus, n (%) 2 (1) 3 (3) 0.334 NEC, n (%) 1 (0.5) 0.680 RDS, n (%) 81 (43) 33 (36) 0.364 Congenital heart disease, n (%) 15 (8) 0.274 PVL, n (%)

Characteristics of very preterm infants Excluded Very Preterms Included Very Preterms p value Gestational age (weeks)* 28 ± 2 0.330 Birth wt (grams) * 1184 ± 409 1114 ± 374 0.204 Length of stay (weeks)* 8.8 ± 5.3 8.9 ± 5.4 0.920 Sex, n (%) 0.670 male 70 (51) 37 (48) female 66 (48) 40 (52) Delivery type, n (%) 0.454 nsvd 41 (31) 20 (26) c/s 55 (41) 39 (51) stat c/s 37 (28) 18 (23) * mean, SD

Characteristics of very preterms Excluded Very Preterms Included Very Preterms p value Multiple gestation, n (%) 0.591 singleton 101 (74) 60 (78) twins 32 (24) 17 (22) triplets 3 (2) 0 (0) Medicaid , n (%) 108 (79) 71 (92) 0.018 Maternal age (years)** 28 ± 6 29 ± 7 0.400 Maternal race, n (%) 0.131 Caucasian 40 (32) 16 (21) African American 27 (21) 21 (28) Hispanic 48 (38) 26 (34) Other 11 (9) 13 (17) Maternal substance abuse, n (%) 2 (1) 7 (9) 0.012 ** mean, SD

Characteristics of very preterms Excluded Very Preterms Included Very Preterms p value BPD, n (%) 28 (21) 18 (23) 0.731 Caffeine, n (%) 100 (76) 60 (78) 0.863 Genetic disorder, n (%) 1 (1) 0.596 Hydrocephalus, n (%) 4 (3) 4 (5) 0.468 NEC, n (%) 14 (10) 5 (6) 0.655 RDS, n (%) 120 (90) 70 (90) 0.816 Congenital heart disease, n (%) 9 (7) 2 (3) 0.335 PVL, n (%) 0.556 ROP, n (%) 7 (9) 0.824