背景與目的：極低出生體重早產兒(出生體重小於1500g)為發展障礙之高危險群。過去文獻顯示西方國家早產兒實施早期介入能夠獲得顯著的神經發展療效，然而東方國家之介入研究甚少，且有關介入療效機轉的探討亦相當有限。因此，本篇研究目的為探討臺灣極低出生體重早產兒以家庭為中心之早期介入於矯正年齡兩歲時之發展功能療效以及檢驗早期神經生理功能的改變是否中介矯正年齡兩歲之神經發展療效。方法: 本研究為多中心臨床實驗已徵召三家醫學中心極低出生體重早產兒並隨機分配於介入組及常規組接受為期一年的介入，兩組早產兒皆於矯正年齡1及4個月使用睡眠腦波測試以及事件相關電位之聽覺特異刺激評估神經生理功能，並於矯正年齡24個月時接受第三版貝萊氏嬰幼兒發展測驗與兒童行爲量表評估，以及收集臨床診斷與健康資料。結果: 以家庭為中心介入組比控制組在矯齡24個月呈現較佳之粗大動作發展(p=0.02)，並且於6到24個月期間有較低的發展遲緩診斷比例 (p=0.03)，然而兩組在認知及語言發展則無顯著差異。在數個早期具明顯神經生理療效的參數中，僅左側額葉之不匹配負向波的平均振幅呈現中介24個月矯齡粗大動作發展療效的趨勢 (p=0.06)。結論：以家庭為中心之早期介入有效改善臺灣極低出生體重早產兒於24個月矯齡之動作發展並降低發展遲緩的比例，所發現之早期神經生理參數有助於了解動作療效的可能神經機轉。

Background and purpose: Preterm infants with very low birth weight (VLBW, birth weight < 1,500 g) are at risk of developmental disabilities. Previous studies showed favorable effect of family-centered intervention on neurobehavioral outcome in preterm infants in Western societies. However, the effect has rarely been elucidated in Eastern societies and the neural mechanism remains unclear. The purposes of this study were therefore to examine the effectiveness of a family-centered intervention program (FCIP) on developmental outcomes in VLBW preterm infants in Taiwan at 24 months of corrected age (CA) compared with a usual care program (UCP) and to assess if early neurophysiological changes mediated the 24-month neurobehavioral outcome. Methods: In a three-centered, randomized controlled trial, VLBW preterm infants were randomly assigned to the FCIP and UCP group for interventions from hospitalization to 12 months CA. Infants were assessed neurophysiological function using the electroencephalography in sleep and event-related potentials in an auditory oddball paradigm at 1 and 4 months CA, followed by neurobehavioral assessment using the Bayley Scales of Infant and Toddler Development- Third Edition (Bayley-III) and behavioral outcome by the Child Behavioral Check List for Ages 1.5-5 (CBCL/1.5-5) at 24 months CA. Clinical diagnosis and heath data were also collected. Results: The FCIP yielded beneficial effect on the gross motor development (p=0.02) and decreased the rate of developmental delay at 6 to 24 months CA (p=0.03) in VLBW preterm infants compared with the UCP. However, the FCIP showed no obvious effect on their cognitive, language and behavioral outcome. Among the significant early neurophysiological variables, only the mean amplitude of mismatch negativity in the left frontal region showed a tendency of mediating the intervention effect on gross motor outcome in preterm infants (p=0.06). Conclusions: Family-centered care favors the motor development and lowers the risk of developmental delay in Taiwanese VLBW preterm infants by 24 months CA than standard care. The identified early neurophysiological parameter provides some clues to the neurological mechanism for motor benefit.

Contents
口試委員會審定書.........................................................................................................i
致謝……………………………………………………………………………………ii
中文摘要.......................................................................................................................iii
English Abstract.............................................................................................................v
Contentss......................................................................................................................vii
Chapter I. Introduction...................................................................................................1
1.1 Epidemiology of preterm birth and developmental disabilities..........................1
1.2 Brain structures and function connectivity in preterm infants............................2
1.3 The relationship between brain structures and developmental outcome............4
1.4 The frameworks of family-centered intervention and effectiveness...................5
1.5 Effect of early intervention on brain structure and neurophysiological functions in preterm infants………………………………………………………………8
1.6 Early intervention for preterm infants in Taiwan…………………………..…11
1.7 Rationale of the study…………………………………………………………13
1.8 Purposes and Hypotheses………………………………………...…………..13
Chapter II. Method……………………………………………………………….…..15
2.1 Participants…………………………………………………………….……...15
2.2 Procedure…………………………………………………………………......16
2.3 Intervention and usual care…….…………………… ………………….....…17
2.4 Outcome measurements……………………………………………………….18
2.4.1 Neurophysiological outcome: EEG coherence and mismatch negativity…………………………………………………………….…18
2.4.2 Bayley Scales of Infant and Toddler Development-III………...………21
2.4.3 Child Behavioral Check List for Ages 1.5-5…………………….……..23
2.4.4 Developmental diagnosis and health outcomes………………………....23
2.5 Statistical analysis……………………….………………………………….…24
Chapter III. Results…………………………………………...……….………..……27
3.1 Study sample …………...………………………..……………...…….……....27
3.2 Significant neurophysiological variables in our follow up study …………….27
3.3 Developmental diagnosis and health outcomes………....……………………28
3.4 Neurobehavioral outcomes at 24 months corrected age: Bayley Scales of Infant and Toddler Development-III………………………………………………..29
3.5 Behavioral outcomes at 24 months corrected age: Child Behavioral Check List for Ages 1.5-5…………………...……….………………………………..….30
3.6 Mediator analysis……………………………………………………………...30
3.7 The EEG variables between developmental delay group and non-developmental delay group…………………………………………...………31
Chapter IV. Discussion………………………………………………….……..…….32
Chapter V. Conclusion………………………………………………………………38
Tables and Figure………………………………………………….............................39
Table 1. Infant and socio-demographic characteristics at 24 months corrected age ...........................................................................................................................39
Table 2. Illustration of significant electrophysiological variables obtained in our previous study.……………………………………………..…………….…….…40
Table 3. Illustration of neurodevelopmental outcomes in the FCIP and UCP group at 24 months corrected age ..…………………………………………….….…….41
Table 4. Illustration of behavioral outcomes in the FCIP and UCP group at 24 months corrected age………………………………….…….……………...…..…42
Table 5. Outpatient clinic record of the FCIP and UCP group from 0 to 24 months corrected age ………………...................................................................................43
Table 6. Emergency visit record from 0 to 12 months corrected age ………….....46
Table 7. Rehospitalization record from 0 to 12 months corrected age ………..….47
Table 8. Illustration of the mediator analysis of 1-month coherence for intervention effect on gross motor outcome in preterm infants…………………...……………48
Table 9. Illustration of the mediation analysis of change of coherence for developmental outcome…………………………………………...………...…….49
Table 10. Illustration of the mediator analysis of ERP for intervention effect on gross motor outcome in preterm infants …………………...……………..…...….50
Table 11. Illustration of the coherence at 1 month by diagnosis of developmental delay …………………………………………………………………………….51
Table 12. Illustration of the change of coherence by diagnosis of developmental delay in delta band……………………………………………………………….52
Table 13. Illustration of the change of coherence by diagnosis of developmental delay in theta band……………………………………………………………….53
Table 14. Illustration of ERP by diagnosis of developmental delay…………….54
Figure 1. Flow chart……………………………………………………………….55
References…………………………………………………………………..……..56
Appendices…………………………………………………………………..….…72
Appendix 1. Program characteristics for the intervention and control groups.....72
Appendix 2. Neonatal morbidity, feeding and growth……………………..……73
Appendix 3. Coding sheets of health record………………………………….....74
Appendix 4. Coding sheets of health record ……………………………..………75

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