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International Journal of Biological Sciences. Int J Med Sci ; 12 4: Department of Pediatrics, Aizenbashi Hospital 6. Department of Pediatrics, Jichi Medical University 9. To evaluate the effect of antenatal corticosteroids ANS on short- and long-term outcomes in small-for-gestational age SGA infants.
A retrospective database analysis was performed. Our results show that ANS does not affect short- or long-term outcome in SGA infants when the birth weight is less than g. Antenatal corticosteroid ANS administration in women who are at risk for preterm labor reduces the incidence of neonatal respiratory distress syndrome [ 1 ], intraventricular hemorrhage IVH , necrotizing enterocolitis NEC , and neonatal mortality [ 2 ].
Although administration of ANS is the most effective intervention for risks associated with preterm birth, the effect in some subgroups is limited. The effects of ANS in multiple pregnancies, in cases of chorioamnionitis CAM [ 3 ], and in cases of growth-restricted fetuses [ 4 ] are unclear. The database includes infants with birth weights at or less than 1, g, herein referred to as very-low-birth-weight VLBW infants, who were treated at participating neonatal centers.
This database contains the factors of the maternal course administered ANS or not , short-term outcomes, and long-term outcomes. In this study, we conducted a retrospective analysis of the effectiveness of ANS on the short- and long-term outcomes in small-for-gestational-age SGA VLBW infants, which is a very high-risk group among preterm infants. Study inclusion process for the short-term outcome evaluation group and the long-term outcome evaluation group.
ANS, antenatal corticosteroids; GA, gestational age. The 82 level III perinatal centers in Japan are registered in the database listed in the Acknowledgments. Data include infants with birth weight less than 1, g. Infants who were born alive but died in the delivery room were also included.
The clinician's perspective on active treatment or withdrawal of care for preterm infants born at 22 and 23 weeks of gestation depended on the clinical status of the infants. After 23 weeks of gestation, most clinicians attempted to save the infants. All other factors were defined as reported previously [ 7 ]. There were 10, clinical cases between and Fig. Exclusion criteria were multiple pregnancies, 34 weeks of gestation or more, uncertain gestational age, uncertain administration of ANS, major congenital malformation, and hospitalization following an out-of-hospital birth.
Short-term outcome evaluation was available in 5, cases. Of those, 3, cases dropped out of the follow-up before 3 years of age; therefore, long-term outcome was evaluated in 2, cases.
A birth weight below the 10th percentile for gestational age was classified as SGA. Birth weight for gestational age was determined using the percentile scale derived from the formula used in Japan [Itabashi, Fujimura, Kusuda, Tamura, Hayashi, et al. J Jpn Pediatr Soc ANS usage was defined as the administration of any corticosteroids to accelerate fetal lung maturity. ANS was provided based on the clinician's policy or perspective.
The time from ANS administration to delivery and the type of corticosteroid used were not described in the database. It is inferred that betamethasone was used in most of the cases because betamethasone is the only drug that is officially recognized in the health insurance system of Japan for the acceleration of fetal lung maturation.
The primary short-term outcome was evaluated based on death occurring before discharge from a participating neonatal intensive care unit death in NICU. IVH was defined as Papile grade I or more. The diagnosis of PVL was made based on either head ultrasound or cranial MRI scans performed at 2 weeks of age or later.
RDS was diagnosed based on the clinical and radiographic findings. CLD was defined when an infant continued to receive supplemental oxygen on the 28th day after birth, and week CLD was defined when an infant continued to receive supplemental oxygen at the 36th week based on postmenstrual age. PDA was diagnosed based on both the echocardiographic findings and clinical evidence of a volume overload due to a left-to-right shunt. For surviving VLBW infants, the follow-up protocol consisted of routine physical and neurological evaluations and developmental assessments at 3 years months of chronological age at each participating center, as reported previously [ 9 ].
The primary long-term outcome was evaluated based on death before 3 years of age or neurodevelopmental impairment NDI. CP was defined as a non-progressive central nervous system disorder characterized by abnormal muscle tone in at least one extremity and abnormal control of movement and posture [ 10 ].
Severe hearing impairment included the need for hearing aids. Visual impairment was defined as unilateral or bilateral blindness diagnosed by an ophthalmologist.
Statistical analysis was performed using the Chi 2 test and t-test, as appropriate. Multivariable logistic regression analyses were performed to assess the effect of ANS on the short- and long-term outcomes.
Statistical analyses were performed using JMP, version 9. All information about the infants was collected anonymously, and the stored data were unlinked from individual data. The protocol of this study was approved by the central internal review board at Tokyo Women's Medical University, where all data were collected and stored. A total of 10, infants were registered in the database between and In total, 4, infants were excluded. A total of 5, patients were evaluated for short-term outcomes.
The ratio of cesarean section to vaginal birth was higher in the ANS group. Gestational age at delivery was earlier and birth weight was lower in the ANS group. To evaluate the effect of ANS on short-term outcome in SGA infants, further analysis was performed using logistic regression analysis. A total of 3, infants were excluded because of the lack of follow-up data until 3 years of age. A total of 2, patients were evaluated for long-term outcome.
Gestational age at delivery was lower, and birth weight was lower in the ANS group. Although severe hearing impairment was uncommon in the ANS group, there was no difference in the incidence of death before 3 years of age and other neurodevelopment impairment factors between the ANS group and the no-ANS group based on the univariate analysis. To evaluate the effect of ANS on long-term outcome in SGA infants, further analysis was performed using logistic regression analysis.
The results of multiple logistic analysis of the short-term outcome showing the adjusted odds ratio of the ANS group compared to the no-ANS group. The results of multiple logistic analysis of the long-term outcome showing the adjusted odds ratio of the ANS group compared with the no ANS group.
Despite the established benefits of antenatal glucocorticoids for neonatal lung function and viability in normal-size premature infants, there is considerable controversy concerning the effectiveness of ANS in growth-restricted premature infants. The authors concluded that the benefits of ANS are not dependent on fetal growth [ 13 ]. The case-control study of 62 pairs with growth-restriction due to placental insufficiency indicated that the survival rate without disability or handicap at 2 years corrected age was higher in the ANS group, but there was a statistically significant negative effect on physical growth in the long-term follow-up at school age.
Early studies showed that that plasma cortisol levels in SGA fetuses were higher than in appropriate-for-gestational-age infants, suggesting that the ANS effect was attenuated [ 15 ].
A recent study of sheep fetuses with uterine artery ligation an induced FGR model showed no changes in surfactant protein gene expression when plasma cortisol concentrations were increased [ 17 ]. These studies suggest reactivity to corticosteroid concerning the pulmonary maturity deficits in FGR. A sheep study demonstrated that carotid blood flow decreased after the administration of betamethasone in an induced FGR model [ 18 ]. In contrast, human growth-restricted fetuses showed absent or reversed end-diastolic umbilical artery flow.
Blood flow in umbilical arteries and veins increased after intramuscular injections of betamethasone in some cases [ 19 ]. Thus, the effects of ANS on the cardiovascular system and on prognosis warrant further investigation. This is the first large sample size retrospective study examining the effect of ANS on long-term outcomes in SGA infants.
The strength of this study is its large sample size. In addition, little distortion of the results due to inconsistent neonatal medical care is expected because the same health insurance system of Japan is provided to most inhabitants. The limitations of our study are that it is a retrospective and multicenter study. Although we excluded major malformation, the causes of SGA vary and are not described in the database, and it is expected that the response to ANS varies according to the cause of SGA.
Another limitation is that the ANS administration rate was low. We suppose the reason for this was that ANS was not authorized in the public insurance institution of Japan until ; our study subjects were born between and In summary, ANS is not effective to improve the short- or long-term outcome of SGA infants when the birth weight is less than g.
We wish to thank the institutions and representative physicians enrolled in the Neonatal Research Network Database in Japan, which include the following: Sapporo City General Hospital: Hattori; Kushiro Red Cross Hospital: Noro; Aomori Prefectural Central Hospital: Amizuka; Iwate Medical University: Chida; Sendai Red Cross Hospital: Takahashi; Akita Red Cross Hospital: Arai; Fukushima Medical University: Imamura; National Fukushima Hospital: Ujiie; University of Tsukuba: Miyazono; Tsuchiura Kyodo General Hospital: Shimizu; Dokkyo Medical University: Suzumura; Jichi Medical University: Kono; Saitama Children's Medical Center: Kunikata; Gunma Children's Medical Center: Fujiu; Kameda Medical Center: Kondo; Tokyo Metropolitan Bokuto Hospital: Aizawa; Tokyo Women's Medical University: Uchiyama; Nihon University Itabashi Hospital: Ito; Kanagawa Children's Medical Center: