Thirteen-Year Outcomes of a Randomized Clinical Trial of Early Preventive Care for Very Preterm Infants and Their Parents
Copyright © 2022 Elsevier Inc. All rights reserved..
OBJECTIVE: To evaluate 13-year outcomes of a randomized controlled trial of preventive care (VIBeS Plus) for infants born very preterm and their parents and examine whether possible effects of intervention varied by family social risk.
STUDY DESIGN: Families were randomized to an intervention arm (n = 61) or a standard care arm (n = 59). The intervention was delivered at home by psychologists and physiotherapists over the infants' first year, focusing on infant development and parental mental health. At 13 years corrected age, cognitive, motor, and behavioral outcomes, and parental mental health were assessed. Primary estimands were between-group mean differences, estimated using multiple imputed regression models.
RESULTS: Follow-up included 81 surviving children (69%). There was little evidence of benefits of the intervention for IQ, attention, executive functioning, working memory, and academic skills regardless of level of social risk. Specifically, mean differences in adolescent cognitive outcomes ranged from -2.0 units (95% CI, -9.9 to 5.9) in favor of standard treatment to 5.1 units (95% CI, -2.3 to 12.5) favoring the intervention. A group-by-social risk interaction was observed only for adolescent motor outcomes, with mean differences favoring the intervention for those at higher social risk (balance, 4.9; 95% CI, 1.3-8.5; total motor, 3.2; 95% CI, 0.3-6.2), but not those at lower social risk (balance, -0.3; 95% CI, -2.4 to 1.9; total motor, 0.03; 95% CI, -1.9 to 2.0). Mean differences in adolescent behavior and parental mental health ranged from -6.6 (95% CI -13.8, 0.5) to -0.2 (95% CI, -1.9 to 1.4) and -1.8 (95% CI, -4.1 to 0.6) to -1.7 (95% CI, -4.3 to 1.0), respectively, indicating a pattern of fewer symptoms in the intervention group.
CONCLUSIONS: Benefits of the intervention persisted for adolescent behavior, with better motor outcomes observed in those from socially disadvantaged families. Replication with larger samples, multiple informant reports, and assessment of quality of life-related outcomes is warranted.
TRIAL REGISTRATION: http://www.anzctr.org.au/: ACTRN12605000492651.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:246 |
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| Enthalten in: |
The Journal of pediatrics - 246(2022) vom: 20. Juli, Seite 80-88.e4 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Stedall, Paulina M [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 28.06.2022 Date Revised 26.07.2022 published: Print-Electronic ANZCTR: ACTRN12605000492651 Citation Status MEDLINE |
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| doi: |
10.1016/j.jpeds.2022.03.013 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM338347143 |
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| 100 | 1 | |a Stedall, Paulina M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Thirteen-Year Outcomes of a Randomized Clinical Trial of Early Preventive Care for Very Preterm Infants and Their Parents |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 28.06.2022 | ||
| 500 | |a Date Revised 26.07.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ANZCTR: ACTRN12605000492651 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVE: To evaluate 13-year outcomes of a randomized controlled trial of preventive care (VIBeS Plus) for infants born very preterm and their parents and examine whether possible effects of intervention varied by family social risk | ||
| 520 | |a STUDY DESIGN: Families were randomized to an intervention arm (n = 61) or a standard care arm (n = 59). The intervention was delivered at home by psychologists and physiotherapists over the infants' first year, focusing on infant development and parental mental health. At 13 years corrected age, cognitive, motor, and behavioral outcomes, and parental mental health were assessed. Primary estimands were between-group mean differences, estimated using multiple imputed regression models | ||
| 520 | |a RESULTS: Follow-up included 81 surviving children (69%). There was little evidence of benefits of the intervention for IQ, attention, executive functioning, working memory, and academic skills regardless of level of social risk. Specifically, mean differences in adolescent cognitive outcomes ranged from -2.0 units (95% CI, -9.9 to 5.9) in favor of standard treatment to 5.1 units (95% CI, -2.3 to 12.5) favoring the intervention. A group-by-social risk interaction was observed only for adolescent motor outcomes, with mean differences favoring the intervention for those at higher social risk (balance, 4.9; 95% CI, 1.3-8.5; total motor, 3.2; 95% CI, 0.3-6.2), but not those at lower social risk (balance, -0.3; 95% CI, -2.4 to 1.9; total motor, 0.03; 95% CI, -1.9 to 2.0). Mean differences in adolescent behavior and parental mental health ranged from -6.6 (95% CI -13.8, 0.5) to -0.2 (95% CI, -1.9 to 1.4) and -1.8 (95% CI, -4.1 to 0.6) to -1.7 (95% CI, -4.3 to 1.0), respectively, indicating a pattern of fewer symptoms in the intervention group | ||
| 520 | |a CONCLUSIONS: Benefits of the intervention persisted for adolescent behavior, with better motor outcomes observed in those from socially disadvantaged families. Replication with larger samples, multiple informant reports, and assessment of quality of life-related outcomes is warranted | ||
| 520 | |a TRIAL REGISTRATION: http://www.anzctr.org.au/: ACTRN12605000492651 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a behavior outcomes | |
| 650 | 4 | |a cognitive outcomes | |
| 650 | 4 | |a developmental care | |
| 650 | 4 | |a early intervention | |
| 650 | 4 | |a motor outcomes | |
| 650 | 4 | |a parental mental health | |
| 650 | 4 | |a premature infant | |
| 650 | 4 | |a randomized controlled trial | |
| 700 | 1 | |a Spencer-Smith, Megan M |e verfasserin |4 aut | |
| 700 | 1 | |a Mainzer, Rheanna M |e verfasserin |4 aut | |
| 700 | 1 | |a Treyvaud, Karli |e verfasserin |4 aut | |
| 700 | 1 | |a Burnett, Alice C |e verfasserin |4 aut | |
| 700 | 1 | |a Doyle, Lex W |e verfasserin |4 aut | |
| 700 | 1 | |a Spittle, Alicia J |e verfasserin |4 aut | |
| 700 | 1 | |a Anderson, Peter J |e verfasserin |4 aut | |
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