Cognitive outcome of early intervention in preterms at 7 and 9 years of age: a randomised controlled trial.

OBJECTIVE: Examine the effect of an early intervention programme on cognitive outcome at 7 and 9 years in children with birth weight (BW) <2000 g. DESIGN: A randomised controlled trial of a modified version of the Mother-Infant Transaction Program. SETTING: A single tertiary neonatal unit. PATIENTS: 146 infants were randomised into a preterm control group (74) or a preterm intervention group (72). INTERVENTIONS: The intervention consisted of eight sessions shortly before discharge and four home visits by specially trained nurses focusing on the infants' unique characteristics, temperament, developmental potential and the interaction between infants and parents. MAIN OUTCOME MEASURES: Outcomes were assessed with the Wechsler Intelligence Scale for Children (WISC-III). RESULTS: Mean BWs were 1396 (429) g in the intervention group and 1381(436) g in the control group. After adjusting for the possible clustering effects of twin pairs and maternal education, there were no significant differences in WISC-III scores at age 7 or 9. The mean difference was 4.1 points (95% CI -1.5 to 9.8 points) in favour of the intervention group at 7 years and 2.2 points (95% CI -3.4 to 7.6 points) at 9 years. At 7 years, a 6.8 points difference in the Verbal Comprehension Index (95% CI 0.5 to 13.0 points) was found in favour of the intervention group. Loss to follow-up at age 7 and 9 was 11% and 14%, respectively. CONCLUSIONS: This intervention programme did not have a sustained significant effect on overall cognitive outcomes in preterm children at age 7 and 9. TRIAL REGISTRATION NUMBER: The trial has been registered at http://www.clinicaltrials.gov (identifier NCT00222456).

Patient comfort during treatment with heated humidified high flow nasal cannulae versus nasal continuous positive airway pressure: a randomised cross-over trial.

OBJECTIVE: To compare patient comfort in preterm infants treated with heated humidified high flow nasal cannulae (HHHFNC) versus nasal continuous positive airway pressure (NCPAP). DESIGN: Randomised cross-over trial (2×24 h). SETTING: Single tertiary neonatal unit. PATIENTS: 20 infants less than 34 weeks postmenstrual age treated with NCPAP due to mild respiratory illness. INTERVENTIONS: After parental consent, infants were randomised to 24 h of treatment with NCPAP or HHHFNC followed by 24 h of the alternate therapy. MAIN OUTCOME MEASURES: Primary outcome was patient comfort assessed by the EDIN (neonatal pain and discomfort) scale. Secondary outcomes were respiratory parameters (respiratory rate, FiO2, SpO2, TcPCO2), ambient noise, salivary cortisol and parental assessments of their child. RESULTS: We found no differences between HHHFNC and NCPAP in mean cumulative EDIN score (10.7 vs 11.1, p=0.25) or ambient noise (70 vs 74 dBa, p=0.18). Parents assessed HHHFNC treatment as significantly better in the three domains, 1) child satisfied, 2) parental contact and interaction and 3) possibility to take part in care. Mean respiratory rate over 24 h was lower during HHHFNC than CPAP (41 vs 46, p=0.001). Other respiratory parameters were similar. CONCLUSIONS: Using EDIN scale, we found no difference in patient comfort with HHHFNC versus NCPAP. However, parents preferred HHHFNC, and during HHHFNC respiratory rate was lower than during NCPAP. CLINICALTRIALSGOV, NUMBER: NCT01526226.