11. Motor dysfunction.
Intervention and comparison | Outcome | Assumed risk with comparator | Corresponding risk with intervention | Relative effect (95% CI) | Number of participants (trials) | Quality of the evidence (GRADE) | Comments |
Neonatal care: asphyxia | |||||||
Therapeutic hypothermia vs standard care for newborns with hypoxic‐ischaemic encephalopathy (Jacobs 2013) | Neuromotor delay (BSID PDI > 2 SD below mean) in survivors assessed at 18 to 24 months | 349 per 1000 (104/298) |
262 per 1000 (206 to 328) | RR 0.75 (0.59 to 0.94) | 657 (6 RCTs) | HIGH | Not downgraded |
Neonatal care: blood disorders | |||||||
Erythropoietin vs placebo for preventing red blood cell transfusion in preterm and/or low birthweight infants (Ohlsson 2014) | PDI < 70 at 18 to 22 months' corrected age (in children examined) | 133 per 1000 (6/45) |
311 per 1000 (131 to 737) | RR 2.33 (0.98 to 5.53) | 90 (1 RCT) | VERY LOW | Study limitations: 1 RCT at unclear risk of selection bias and high risk of attrition bias (˜73% follow‐up) Imprecision (‐2): wide CI crossing line of no effect; 1 RCT with small sample size |
Neonatal care: pulmonary hypertension | |||||||
Endothelin receptor antagonists vs placebo for persistent pulmonary hypertension in term and late preterm infants (More 2016) | Adverse neurological outcomes at 6 months (defined as clinical or electrographically proven seizures, abnormal muscle tone, abnormal deep tendon reflexes, delayed motor milestones, or abnormal auditory brainstem response) | 286 per 1000 (4/14) |
20 per 1000 (0 to 343) | RR 0.07 (0.00 to 1.20) | 37 (1 RCT) | LOW | Study limitation (‐1): 8/23 infants in the placebo group were excluded from analysis Imprecision (‐1): single RCT, small sample size (graded by review authors themselves) |
Neonatal care: resuscitation | |||||||
Room air vs 100% oxygen for resuscitation of infants at birth (Tan 2005) | Not walking in those followed up at 18 to 24 months | 107 per 1000 (13/122) |
110 per 1000 (4 to 240) | RR 1.03 (0.04 to 2.25) | 213 (1 RCT) | VERY LOW | Study limitations (‐2): 1 qRCT with no blinding, and < 70% follow‐up Imprecision (‐1): wide CI crossing line of no effect |
Neonatal care: nitric oxide | |||||||
Inhaled NO vs placebo for respiratory failure in preterm infants (studies of routine use in intubated preterm infants) (Barrington 2010) | BSID MDI or PDI < ‐ 2 SD at 2 years' corrected age | 412 per 1000 (28/68) |
231 per 1000 (136 to 383) | RR 0.56 (0.33 to 0.93) | 138 (1 RCT) | MODERATE | Study limitations (‐1): 1 small RCT with 82% follow‐up |
Inhaled nitric oxide vs control for respiratory failure in infants born at or near term (Finer 2006) | BSID PDI > 2 SD below the mean at 13 or 18 to 24 months | 148 per 1000 (25/169) |
161 per 1000 (86 to 300) | RR 1.09 (0.58 to 2.03) | 283 (2 RCTs) | LOW | Study limitations (‐1): 1 RCT masking of allocation, masking of outcomes, and completeness of follow‐up 'can't tell' Inconsistency (‐1): substantial heterogeneity (I² = 77%) Note: error in review for Ninos 1996 data; intervention and control group data switched; this has been rectified in this analysis |
Neonatal care: respiratory distress syndrome | |||||||
Inositol supplementation (repeat doses) vs placebo in preterm infants at risk for or having respiratory distress syndrome (Howlett 2015) | Minor neural developmental impairment at 1 year corrected age (defined as sensorimotor abnormality and/or developmental delay) | 137 per 1000 (10/73) |
115 per 1000 (52 to 255) | RR 0.84 (0.38 to 1.86) | 169 (1 RCT) | VERY LOW | Study limitations (‐1): 1 RCT at unclear risk of selection, performance, detection, and reporting bias, and at high risk of other bias Imprecision (‐2): wide CI crossing line of no effect; 1 RCT with small sample size |
Neonatal care: mechanical ventilation | |||||||
Volume‐targeted vs pressure‐limited ventilation in the neonate (Wheeler 2010) | Gross Motor Developmental Issue (any definition) at 6 to 18 months (defined as gross motor delay) | 172 per 1000 (11/64) |
172 per 1000 (81 to 368) | RR 1.00 (0.47 to 2.14) | 128 (1 RCT) | LOW | Imprecision (‐2): wide CI crossing line of no effect; 1 small RCT (post hoc analysis in review) |
Neonatal care: bronchopulmonary dysplasia | |||||||
Early (< 8 days) postnatal corticosteroids vs placebo for preventing chronic lung disease in preterm infants (Doyle 2014b) | BSID PDI < ‐ 2 SD at 18 to 22 months or 25 months | 146 per 1000 (61/419) |
170 per 1000 (124 to 233) | RR 1.17 (0.85 to 1.60) | 842 (3 RCTs) | MODERATE | Imprecision (‐1): wide CI crossing line of no effect |
BSID PDI < ‐ 2 SD in tested survivors at 18 to 22 months or 25 months | 232 per 1000 (61/263) |
271 per 1000 (202 to 364) | RR 1.17 (0.87 to 1.57) | 528 (3 RCTs) | MODERATE | Imprecision (‐1): wide CI crossing line of no effect | |
Late (> 7 days) postnatal corticosteroids vs placebo or no treatment for chronic lung disease in preterm infants (Doyle 2014) | BSID PDI < ‐ 2 SD at 1 year corrected age | 180 per 1000 (11/61) |
141 per 1000 (61 to 325) | RR 0.78 (0.34 to 1.80) | 118 (1 RCT) | LOW | Imprecision (‐2): wide CI crossing line of no effect; 1 RCT with small sample size |
BSID PDI < ‐ 2 SD in survivors assessed at 1 year corrected age | 256 per 1000 (11/43) |
171 per 1000 (77 to 384) | RR 0.67 (0.30 to 1.50) | 90 (1 RCT) | LOW | Imprecision (‐2): wide CI crossing line of no effect; 1 RCT with small sample size | |
Early inhaled corticosteroids vs placebo for preventing chronic lung disease in ventilated very low birthweight preterm neonates (Shah 2012) | Mean developmental index on BSID‐II < 2 SD of the mean (age not reported in review;from trial manuscript: 3 years) | 143 per 1000 (4/28) |
179 per 1000 (53 to 596) | RR 1.25 (0.37 to 4.17) | 56 (1 RCT) | VERY LOW | Study limitations (‐1): 1 RCT at unclear risk of selection bias and detection bias Imprecision (‐2): wide CI crossing line of no effect; 1 small RCT |
Neonatal care: other | |||||||
Early developmental intervention vs standard follow‐up post hospital discharge to prevent motor and cognitive impairment in preterm infants (Spittle 2015) | Motor outcome at school age (5 years) (defined as low score on Movement ABC) | 378 per 1000 (51/135) |
423 per 1000 (329 to 544) | RR 1.12 (0.87 to 1.44) | 333 (2 RCTs) | LOW | Study limitations (‐1): 2 RCTs at high risk of attrition bias and unclear risk of performance bias Imprecision (‐1): wide CI crossing line of no effect |
Abbreviations: BSID: Bayley Scales of Infant Development; CI: confidence interval; GRADE: Grades of Recommendation, Assessment, Development and Evaluation; MDI: Mental Development Index; Movement ABC: Movement Assessment Battery for Children; PDI: Psychomotor Development Index; qRCT: quasi‐randomised controlled trial; RCT: randomised controlled trial; RR: risk ratio; SD: standard deviation