The “Fortilat” Randomized Clinical Trial Follow-Up: Neurodevelopmental Outcome at 18 Months of Age
Abstract
:1. Introduction
2. Materials and Methods
2.1. Clinical Trial and Intervention
2.2. The Fortilat Follow-Up Protocol
2.3. Subjects and Statistical Analysis
3. Results
3.1. GQ in Continuous
3.2. GQ in Two Classes
4. Discussion
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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BF-arm N = 54 | DF-arm N = 49 | ||
---|---|---|---|
Boys | n (%) | 25 (46.3) | 24 (49.0) |
GA < 32 weeks | n (%) | 44 (81.5) | 33 (67.4) |
GA (days) | median (IQR) | 209 (193–218) | 221 (210–226) |
Minor Neurological Sequelae | n (%) | 7 (13.0) | 9 (18.4) |
Major Neurological Sequelae | n (%) | 0 (0.0) | 1 (2.0) |
Broncho Pulmonary Dysplasia | n (%) | 9 (16.7) | 3 (6.1) |
RDS | n (%) | 47 (87.0) | 40 (81.6) |
Intraventricular hemorrhage | n (%) | 6 (11.1) | 3 (6.1) |
Periventricular leukomalacia | n (%) | 0 (0.0) | 0 (0.0) |
Patent Ductus Arteriosus | n (%) | 17 (31.5) | 7 (14.3) |
Fetal Growth Restriction | n (%) | 17 (32.1) | 25 (51.0) |
Retinopathy of prematurity | n (%) | 9 (16.7) | 4 (8.2) |
Necrotizing Enterocolitis | n (%) | 0 (0.0) | 0 (0.0) |
Length of stay | median (IQR) | 44.5 (32–70) | 35 (29–51) |
Birth head circumference * | |||
cm | mean (SD) | 26.3 (2.29) | 27.0 (2.12) |
z-score Int21s | mean (SD) | −0.54 (1.00) | −1.07 (1.04) |
<10th centile Int21st | n (%) | 16 (30.2) | 21 (42.9) |
>90th centile Int21st | n (%) | 1 (1.9) | 0 (0.0) |
z−score INeS | mean (SD) | −0.32 (1.07) | −0.97 (1.13) |
<10th centile INeS | n (%) | 12 (22.2) | 20 (40.8) |
>90th centile INeS | n (%) | 4 (7.4) | 2 (3.9) |
Birth length ** | |||
cm | 36.6 (3.03) | 37.5 (2.73) | |
z-score Int21s | mean (SD) | −1.00 (0.87) | −1.59 (1.23) |
<10th centile Int21st | n (%) | 15 (35.7) | 23 (59.0) |
>90th centile Int21st | n (%) | 0 (0.0) | 0 (0.0) |
z-score INeS | mean (SD) | −0.58 (1.00) | −1.26 (1.28) |
<10th centile INeS | n (%) | 11 (25.6) | 20 (51.3) |
>90th centile INeS | n (%) | 1 (2.3) | 2 (5.1) |
Birth weight | |||
g | mean (SD) | 1116 (310.0) | 1192 (290.5) |
z-score Int21s | mean (SD) | −0.78 (1.13) | −1.37 (1.12) |
<10th centile Int21st (SGA) | n (%) | 21 (39.6) | 27 (55.1) |
>90th centile Int21st (LGA) | n (%) | 1 (1.9) | 0 (0.0) |
z-score INeS | mean (SD) | −0.41 (1.10) | −1.03 (1.06) |
<10th centile INeS (SGA) | n (%) | 14 (25.9) | 21 (42.9) |
>90th centile INeS (LGA) | n (%) | 3 (5.6) | 0 (0.0) |
Parameter | Intergrowth 21st | INeS | ||
---|---|---|---|---|
Estimate ± SE | p | Estimate ± SE | p | |
Intercept | 302.5 ± 94.5 | 0.0019 | 291.7 ± 91.9 | <0.0001 |
Arm: DF vs. BF | −11.9 ± 8.9 | 0.1853 | −11.9 ± 8.9 | 0.1857 |
Birth head (z−score) | 1.77 ± 4.84 | 0.7160 | 1.78 ± 4.38 | 0.6857 |
BPD: yes vs. no | −4.30 ± 16.19 | 0.7911 | −5.17 ± 15.94 | 0.7466 |
Minor neurological sequelae: yes vs. no | −35.0 ± 12.2 | 0.0051 | −34.2 ± 12.0 | 0.0053 |
GA (weeks) | 2.84 ± 2.90 | 0.3310 | 3.15 ± 2.83 | 0.2680 |
Population: GA < 32 wks vs. GA ≥ 32 wks | −4.29 ± 14.8 | 0.7733 | −3.22 ± 14.4 | 0.8236 |
<Q1 | ≥Q1 | |
---|---|---|
BF-arm | 13 | 41 |
DF-arm | 16 | 33 |
Intergrowth21st | INeS | |||
---|---|---|---|---|
OR [CI (95%)] | p | OR [CI (95%)] | p | |
Arm: DF vs. BF | 1.887 (0.665; 5.352) | 0.2325 | 1.941 (0.680; 5.540) | 0.2152 |
Birth head (z-score) | 0.832 (0.476; 1.452) | 0.5171 | 0.898 (0.545; 1.480) | 0.6743 |
BPD: yes vs. no | 2.007 (0.371; 10.863) | 0.4190 | 2.312 (0.437; 12.223) | 0.2824 |
Minor neurological sequelae: yes vs. no | 4.319 (1.267; 14.726) | 0.0194 | 3.930 (1.174;13.159) | 0.0264 |
GA (weeks) | 0.872 (0.625; 1.215) | 0.4173 | 0.839 (0.609; 1.156) | 0.3239 |
Population: GA < 32 wks vs. GA ≥ 32 wks | 0.655 (0.121; 3.546) | 0.6232 | 0.520 (0.102;2.660) | 0.4327 |
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Peila, C.; Spada, E.; Deantoni, S.; Iuliano, E.; Moro, G.E.; Giribaldi, M.; Cavallarin, L.; Cresi, F.; Coscia, A. The “Fortilat” Randomized Clinical Trial Follow-Up: Neurodevelopmental Outcome at 18 Months of Age. Nutrients 2020, 12, 3807. https://0-doi-org.brum.beds.ac.uk/10.3390/nu12123807
Peila C, Spada E, Deantoni S, Iuliano E, Moro GE, Giribaldi M, Cavallarin L, Cresi F, Coscia A. The “Fortilat” Randomized Clinical Trial Follow-Up: Neurodevelopmental Outcome at 18 Months of Age. Nutrients. 2020; 12(12):3807. https://0-doi-org.brum.beds.ac.uk/10.3390/nu12123807
Chicago/Turabian StylePeila, Chiara, Elena Spada, Sonia Deantoni, Ester Iuliano, Guido E. Moro, Marzia Giribaldi, Laura Cavallarin, Francesco Cresi, and Alessandra Coscia. 2020. "The “Fortilat” Randomized Clinical Trial Follow-Up: Neurodevelopmental Outcome at 18 Months of Age" Nutrients 12, no. 12: 3807. https://0-doi-org.brum.beds.ac.uk/10.3390/nu12123807