A Randomized Controlled Trial of Synchronized Nasal Intermittent Positive Pressure Ventilation in RDS

V Bhandari; R G Gavino; J H Nedrelow; P Pallela; A Salvador; R A Ehrenkranz; N L Brodsky;

Disclosures

December 05, 2007

In This Article

Results

Whereas 18 babies were recruited from AEMC (CV, n=8; SNIPPV, n=10), 23 were enrolled at Yale site (CV, n=13; SNIPPV, n=10). There were no significant differences in the data from AEMC and Yale site. Hence, the combined data is shown, unless specified otherwise.

The maternal and infant characteristics of the groups randomized to CV or SNIPPV were similar as shown in Table 1 . BW and GA were similar in both groups ( Table 2 ). Significantly more babies in the CV group had the primary outcome of BPD/death, compared to the SNIPPV group (52 versus 20%, P=0.03; Table 2 ). There was no difference in the total duration of supplemental oxygen or PPV (duration of endotracheal tube ventilation or SNIPPV; Table 3 ). There were no differences in the blood gases (pH, pCO2, pO2 and HCO3) at 1, 6, 24 and 48 h post-surfactant in the two groups (detailed blood gas information is only available from the Yale site; data not shown). The incidence of air leaks, PDA, IVH, PVL, GER, NEC and ROP was similar in both groups ( Table 3 ). Five of the total six babies died of respiratory failure, one of NEC at a mean age of 41.2 (±s.d., ±27.36) days.

The number of babies who were re-intubated after extubation during their stay in the nursery was similar in both groups. Excluding babies who died, there were nine (45%) babies in the SNIPPV group and eight (38%) in the CV group that were re-intubated (P=0.65).

Surviving infants were invited back for neurodevelopmental follow-up at both sites. In accordance with center practices, only babies with BW≤1000 g were followed at Yale site, whereas all babies were invited to return to AEMC for follow-up. Only two babies (one each in CV and SNIPPV groups) were excluded for neurodevelopmental follow-up at Yale site. Of the remaining survivors at both sites, data were available from 15 infants, eight in the CV group and seven in the SNIPPV group. The neurodevelopmental assessment (using Bayley Scales of Development II)[24] was performed by trained and certified personnel who were masked to the infant's group assignment. There were no statistically significant differences in the mental developmental index (MDI) (mean±s.d.; CV versus SNIPPV; 88.13±10.32 versus 81.43±17.54) or psychomotor developmental index (PDI) (88.38±11.87 versus 84.29±19.47) scores in the infants in the two groups, assessed at a median (25th to 75th centile) corrected GA of 22 (20.5 to 24) months.

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