CUTIES trial
Research type
Research Study
Full title
Crying Unsettled and disTressed Infants: Effectiveness Study of osteopathic care: a randomised controlled trial
IRAS ID
268925
Contact name
Dawn Carnes
Contact email
Sponsor organisation
University College of Osteopathy
Duration of Study in the UK
1 years, 10 months, days
Research summary
Background: Infants who excessively cry, are distressed and unsettled can have a marked impact on family life. Around 1 in 6 families are affected, it is associated with maternal depression, anxiety and loss of parenting confidence. These infant behaviors are usually self-limiting (subsiding around 12 weeks after birth) but during this difficult period many parents look for additional support. There is limited research and much debate about the effectiveness of manual therapy and osteopathic care for these infants.
Aim: To evaluate the effectiveness and healthcare cost of osteopathic care for excessively crying, unsettled and distressed infants (=< 10 weeks old).
Method: We propose a two-arm pragmatic randomised controlled trial. We will need to randomise 202 parent(s)/carers and their infants to either: i) Osteopathic manual therapy with best usual care advice and support or, ii) Light touch attention control (equal time and touch spent with infant) with best usual care advice and support. Parents will be blinded to whether their infant receives the manual therapy care or not. This design will enable us to test the addition of the active manual therapy component against light touch best usual care and advice alone. The cost of the delivery of the intervention will be determined and compared with data about the cost of other care.
Population: Healthy infants 10 weeks old or under, reported by their parent(s)/carers as excessively crying, unsettled and distressed, > 3 hours of crying per day, for 3 days or more for 1 week or more. Infants with diagnosed health conditions for which they are receiving medical treatment will be excluded from the study.
Outcomes: The primary outcome is reduced infant crying time over 14 days. Secondary outcomes are: i) Parental self-efficacy ii) Parent perceived global improvement iii) Satisfaction with treatment and iv) Adverse events.REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/1620
Date of REC Opinion
6 Nov 2019
REC opinion
Further Information Favourable Opinion