The Effect of Maternal Lullaby Singing, Affectionate Touch, and a Developmental Support Program on Comfort and Development in Premature Infants: A Randomized Controlled Trial.

The outcome assessor was not blinded, and one researcher performed the comfort and developmental assessments, so observer bias is possible. No formal allocation concealment method was used, so selection bias in group assignment cannot be completely excluded. The intervention group had a higher pre-intervention PICS score in week 1, which means lower comfort, so week 1 comfort changes may partly reflect starting point rather than treatment. Many comfort and developmental outcomes were tested across weeks and subskills, and most findings that looked significant did not remain significant after the multiple-outcome check. Of 68 randomised infants, 57 were analysed; losses included infant deaths, a tracheostomy, family circumstances, and inability to contact families. The intervention combined lullaby singing, affectionate touch, and the home developmental programme, so the contribution of any single component cannot be separated. The study was single-site and followed development for only 3 months, so long-term effects are unknown.

The authors report no funding and no conflicts of interest.

Do not conclude that lullaby singing, affectionate touch, and the home developmental programme improve premature infant development. The study tested many comfort and developmental outcomes, and most significant findings did not hold up after the authors checked for false positives. The surviving findings were limited, and the study cannot separate which of the combined components produced them.