Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Participants
2.3. Sample Size
2.4. Randomization and Masking
2.5. Intervention
2.6. Measures
2.7. Statistical Analysis
3. Results
3.1. Primary Outcome Measure (AIMS)
3.2. Secondary Outcome Measures
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Children Characteristics | IG (n = 24) | CG (n = 24) | p-Value |
---|---|---|---|
Gestational age at birth, M (SD) (weeks) | 31.84 (1.82) | 32.05 (1.59) | 0.675 a |
Prematurity classification, n (%) | |||
Moderate premature 32 < 34 | 13 (48.1) | 14 (51.9) | 0.771 c |
Very premature 28 < 32 | 11 (52.4) | 10 (47.6) | |
Intrauterine growth restriction, n (%) | 4 (16.7) | 6 (25.0) | 0.724 b |
Birth weight, M (DE) (g) | 1462.46 (437.27) | 1590.79 (331.21) | 0.258 a |
Cranial circumference at birth, M (SD) (cm) | 27.75 (2.61) | 28.48 (1.51) | 0.247 a |
Gender, n (%) | |||
Girls | 12 (50.0) | 8 (33.3) | 0.242 c |
Boys | 12 (50.0) | 16 (66.7) | |
Twins, n (%) | 8 (33.3) | 8 (33.3) | 1.000 c |
Cesarean birth, n (%) | 14 (58.3) | 12 (50.0) | 0.562 c |
Assisted reproduction, n (%) | 9 (37.5) | 5 (20.8) | 0.204 c |
Antibiotic therapy, n (%) | |||
Yes | 10 (41.7) | 8 (33.3) | 0.551 c |
No | 14 (58.3) | 16 (66.7) | |
Oxygen therapy, n (%) | |||
Yes | 4 (16.7) | 4 (16.7) | 1.000 b |
No | 20 (83.3) | 20 (83.3) | |
Jaundice with phototherapy, n (%) | |||
Yes | 17 (70.8) | 17 (70.8) | 1.000 c |
No | 7 (29.2) | 7 (29.2) | |
Caffeine, n (%) | |||
Yes | 13 (54.2) | 14 (58.3) | 0.771 c |
No | 11 (45.8) | 10 (41.7) | |
Hospital admission days, M (SD) | 37.00 (19.12) | 32.25 (17.04) | 0.368 a |
Weight at hospital discharge, M (SD) (g) | 2086.67 (283.05) | 2096.46 (236.83) | 0.897 a |
Cranial circumference at discharge, M (SD) (cm) | 32.42 (3.91) | 31.38 (1.24) | 0.224 a |
Mother Characteristics | IG (n = 20) | CG (n = 20) | p-Value |
---|---|---|---|
Age, M (DE) (years) | 33.80 (5.95) | 32.20 (6.26) | 0.413 a |
Education level, n (%) | |||
Primary | 1 (5.0) | 2 (10.0) | 0.160 b |
High school | 2 (10.0) | 7 (35.0) | |
Medium | 11 (55.0) | 6 (30.0) | |
Undergraduate | 6 (30.0) | 5 (25.0) | |
Father characteristics | IG (n = 20) | CG (n = 19) | pvalue |
Age, M (DE) (years) | 33.40 (4.83) | 33.74 (7.24) | 0.866 a |
Education level, n (%) | |||
Primary | 0 (0.0) | 1 (5.3) | 0.259 b |
High school | 3 (15.0) | 3 (15.8) | |
Medium | 11 (55.0) | 12 (63.2) | |
Undergraduate | 6 (30.0) | 3 (15.8) |
AIMS | 2 Months Corrected Age | 8 Months Corrected Age | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
IG (n = 20) | CG (n = 22) | p-Value a | Z Mann Whitney | Effect Size b | IG (n = 20) | CG (n = 21) | p-Value a | Z Mann Whitney | Effect Size b | |
Prone, M (SD) | 2.30 (1.13) | 2.73 (0.99) | 0.121 | −1.550 | −0.239 | 12.30 (4.04) | 12.33 (3.53) | 0.875 | −0.157 | −0.025 |
Supine, M (SD) | 3.15 (0.37) | 3.36 (0.58) | 0.190 | −1.310 | −0.202 | 7.30 (1.42) | 7.29 (1.42) | 0.989 | −0.013 | −0.002 |
Sitting, M (SD) | 1.05 (0.22) | 1.05 (0.38) | 0.980 | −0.025 | −0.004 | 7.55 (2.95) | 8.76 (2.05) | 0.230 | −1.201 | −0.188 |
Standing positions, M (SD) | 1.25 (0.64) | 1.55 (0.60) | 0.118 | −1.563 | −0.241 | 3.10 (0.97) | 3.67 (1.02) | 0.063 | −2.921 | −0.456 |
Total score, M (SD) | 7.80 (1.20) | 8.55 (1.50) | 0.073 | −1.793 | −0.277 | 30.25 (7.15) | 32.10 (6.83) | 0.396 | −1.045 | −0.163 |
ASQ-3 | 1 Month Corrected Age | 8 Months Corrected Age | ||||||||
IG (n = 20) | CG (n = 23) | pValue a | Z Mann Whitney | Effect Size b | IG (n = 20) | CG (n = 23) | pValue a | Z Mann Whitney | Effect Size b | |
Gross Motor, M (SD) | 50.00 (5.85) | 49.13 (7.18) | 0.830 | −0.215 | −0.033 | 38.25 (14.63) | 41.09 (13.73) | 0.532 | −0.625 | −0.095 |
Fine Motor, M (SD) | 53.50 (5.16) | 42.17 (8.64) | 0.000 | −4.202 | −0.641 | 55.50 (6.05) | 54.78 (5.93) | 0.517 | −0.648 | −0.099 |
Problem Solving, M (SD) | 49.25 (7.83) | 37.39 (14.91) | 0.006 | −2.725 | −0.416 | 52.50 (7.69) | 55.00 (5.22) | 0.351 | −0.932 | −0.142 |
Personal-Social, M (SD) | 46.25 (5.10) | 41.96 (6.70) | 0.049 | −1.972 | −0.301 | 47.00 (11.17) | 50.87 (8.61) | 0.263 | −1.120 | −0.171 |
Communication, M (SD) | 38.00 (12.61) | 26.52 (13.52) | 0.006 | −2.740 | −0.418 | 51.00 (9.40) | 51.30 (7.10) | 0.870 | −0.163 | 0.025 |
ASQ-3 at 1 Month Corrected Age | IG (n = 20) | CG (n = 23) | p-Value a |
---|---|---|---|
Gross Motor, n (%) | 0.588 | ||
High-risk | 2 (10.0) | 4 (17.4) | |
Follow-up | 4 (20.0) | 4 (17.4) | |
Correct | 14 (70.0) | 15 (65.2) | |
Fine Motor, n (%) | 0.003 | ||
High-risk | 0 (0) | 4 (17.4) | |
Follow-up | 1 (5.0) | 7 (30.4) | |
Correct | 19 (95.0) | 12 (52.2) | |
Problem Solving, n (%) | 0.004 | ||
High-risk | 0 (0) | 6 (26.1) | |
Follow-up | 1 (5.0) | 4 (17.4) | |
Correct | 19 (95.0) | 13 (56.5) | |
Personal-Social, n (%) | 0.079 | ||
High-risk | 0 (0) | 2 (8.7) | |
Follow-up | 5 (25.0) | 9 (39.1) | |
Correct | 15 (75.0) | 12 (52.2) | |
Communication, n (%) | 0.003 | ||
High-risk | 2 (10.0) | 9 (39.1) | |
Follow-up | 6 (30.0) | 10 (43.5) | |
Correct | 12 (60.0) | 4 (17.4) |
Parenting Stress Index (PSI-SF) | IG (n = 16) | CG (n = 19) | p-Value a | Size Effect b |
---|---|---|---|---|
Parental Distress, M (SD) | 26.38 (10.51) | 27.05 (8.46) | 0.834 | 0.07 |
Parent–Child Dysfunctional Interaction, M (SD) | 19.69 (5.63) | 18.84 (4.63) | 0.629 | 0.16 |
Difficult Child, M (SD) | 21.75 (7.79) | 21.21 (5.35) | 0.810 | 0.08 |
Total Stress, M (SD) | 68.31 (21.94) | 67.11 (16.24) | 0.853 | 0.06 |
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Ochandorena-Acha, M.; Terradas-Monllor, M.; López Sala, L.; Cazorla Sánchez, M.E.; Fornaguera Marti, M.; Muñoz Pérez, I.; Agut-Quijano, T.; Iriondo, M.; Casas-Baroy, J.C. Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial. Children 2022, 9, 895. https://doi.org/10.3390/children9060895
Ochandorena-Acha M, Terradas-Monllor M, López Sala L, Cazorla Sánchez ME, Fornaguera Marti M, Muñoz Pérez I, Agut-Quijano T, Iriondo M, Casas-Baroy JC. Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial. Children. 2022; 9(6):895. https://doi.org/10.3390/children9060895
Chicago/Turabian StyleOchandorena-Acha, Mirari, Marc Terradas-Monllor, Laura López Sala, Maria Engracia Cazorla Sánchez, Montserrat Fornaguera Marti, Isabel Muñoz Pérez, Thais Agut-Quijano, Martín Iriondo, and Joan Carles Casas-Baroy. 2022. "Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial" Children 9, no. 6: 895. https://doi.org/10.3390/children9060895