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Adding swaddling to behaviour modification in infant care did not reduce excessive crying in healthy infants <13 weeks of age at randomisation

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Q Does behaviour modification of infant care (ie, regularity of care and stimulus reduction) plus swaddling reduce excessive crying in healthy infants?


Embedded ImageDesign:

randomised controlled trial.

Embedded ImageAllocation:


Embedded ImageBlinding:

{data collectors and data analysts}.*

Embedded ImageFollow up period:

12 weeks.

Embedded ImageSetting:

Utrecht, The Hague, Arnhem, and Raalte/Zwolle, the Netherlands.

Embedded ImageParticipants:

398 healthy infants who were ⩽12 weeks and 6 days of age, ⩾32 weeks gestational age, and cried excessively (>3 h/d for ⩾3 d/wk) according to parents, doctors, or healthcare workers. After a 1 week baseline period during which all infants were fed hypoallergenic formula (or if breastfed, maternal diet was free of milk, egg, wheat, or nut products), infants were excluded if crying decreased to <2 hours/day from day 3/4 or if …

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  • * Information provided by author.

  • For correspondence: Dr B E van Sleuwen, Wilhelmina Children’s Hospital, University Medical Center Utrecht, The Netherlands. B.E.vanSleuwen{at}

  • Sources of funding: The Netherlands Organization for Health Research and Development; Frisocare provided hypoallergenic formula and Weleda Nederland NV provided swaddling cloths.