Abstract
We report a prospective double-blind randomised cross over trial designed to compare the effect of a hypoallergenic formula NAN-HA with a standard cows' milk protein (whey dominant) formula NAN on 67 infants (45 M, 22 F) aged 6 weeks to 6 months. Records of sleep, crying, diarrhoea, colic, regurgitation, skin rashes and coughs and wheezing were recorded for 2 three-week periods (one on each formula) following an initial one week run-in period. Night sleep (between 8pm and 8am) was confirmed to be less initially in the “sleep disturbed” infants compared to controls (p < 0.01). Sleep improved in the infants whether allocated HA or NAN first and improved throughout the 6 weeks of the trial to be no different from control infants at the end. There was no significant difference between the two groups with respect to any of the symptoms studied except that loose stools/diarrhoea were significantly increased (p < 0.01) on HA. 22 mothers completed the cross over design; 14 expressed a preference for the HA formula and only 8 for NAN. We cannot therefore confirm that the hypoallergenic milk (HA) improves sleep in a group of sleep disturbed infants.
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