Of the 10
835 babies born alive during the 2 year recruitment period, 9712 (89.6%) were eligible for randomisation; 4835 were allocated to the one screen policy and 4877 to the two screen policy (figure). We could not link data on 1.6% of babies; the numbers lost to follow up because of death (n=7) or moving out of the area were similar in both groups. The groups’ baseline characteristics were similar in respect of sex, mode of delivery, birth order, and weight (table ). Length of stay was the same in both groups (median (interquartile range) 4 (2 to 6) days).
Baseline characteristics of trial babies* according to whether they underwent one or two neonatal screening examinations before discharge from hospital. Values are numbers (percentages) of babies unless stated otherwise
In practice 459 (9.5%) of the one screen policy group were actually examined twice, and 766 (15.7%) of the two screen policy group were examined once. Reasons for failure to adhere to protocol included detection of serious physical abnormality within the first 24 hours, failure to change from one policy to the other at the start of a month, and babies going home early. Babies allocated to the one screen policy were less likely ever to be examined by a senior member of staff (56%) compared with 85% examined at least once by a senior doctor under the two screen policy (difference 28%; 95% confidence interval 26% to 30%). Of the two screen policy babies, 32% were examined on day 4 or later compared with 3% in the one screen policy group.
Significantly fewer conditions were diagnosed in hospital among one screen policy babies than two screen policy babies (8.3 v 9.9; difference 1.6; 0.3 to 2.7; table ). This was largely because of fewer suspected musculoskeletal problems, especially suspected hip anomalies (2.8 v 3.6; difference 0.8; 0.1 to 0.5).
Congenital diagnoses in neonates at discharge from hospital after birth* according to whether they underwent one or two neonatal screening examinations
Of the babies for whom we could link data, 37 (0.38%) failed to have an assessment at 8 weeks. There was no evidence of an excess of abnormal findings between the groups at either the 8 week or the 8 month community assessment (table ). Nor were there more followed up in primary care or referred to secondary care from this community screening programme, both overall and among the 10% subsample.
Table 3 Routine assessments at 8 weeks and 8 months of age and contacts with general practitioners in first year in babies according to whether they underwent one or two neonatal screening examinations before discharge from hospital. Values are numbers (percentages (more ...)
Although the difference in the proportions of babies attending outpatient clinics in their first year of life was not significant (18.5% v 19.9%; difference −1.4%; 2.9% to 0.1%; table ), the observed difference was largely explained by more attendances at the orthopaedic outpatient clinic (6.0% v 7.0%; difference −1%; −1.9% to −0.02%).
Outpatient and inpatient care in first year of life in babies according to whether they underwent one or two neonatal screening examinations before discharge from hospital after birth. Values are numbers (percentages) of babies
In their first year of life 1471 (15%) babies were admitted as inpatients at least once; of these, 369 (3.8%) were admitted more than once (table ). There were no apparent differences between the two groups in the proportion of admissions, the type (whether planned or emergency), or the specialty.
There were no clear differences between the groups in the number with a primary diagnosis of a congenital condition at their first admission (1.0 v 0.7 diagnoses per 100 babies; difference 0.3; −0.1 to 0.7) or any admission (1.6 v 1.4 diagnoses per 100 babies; difference 0.2; −0.3 to 0.7).
The larger number of hip anomalies suspected in hospital under the two screen policy (see table ) was reflected in more babies being seen at the orthopaedic clinic (125 v
176; table ). There was no difference, however, in the proportion who received active management (outpatient splinting or surgical reduction 0.3% v
0.2%; difference 0.1%; −0.1% to 0.3%; table ). For babies who had been judged normal in hospital (on the basis of a negative Ortolani-Barlow manoeuvre10
) there was no clear difference in the proportion subsequently referred nor in those who then required active management (0.2% v
0.1%; difference 0.1%; −0.1% to 0.2%; table ). This applied also to those referred because of a family history (table ). There was no difference in the proportion of babies confirmed to have a cardiac anomaly between the two groups irrespective of whether or not they were diagnosed in hospital (table ).
Follow up of trial babies at orthopaedic and cardiac clinics according to whether they underwent one or two neonatal screening examinations before discharge from hospital after birth. Values are numbers (percentages) of babies