Table 1

Outcome measures
Construct Timing (D = days/M = months) Measure Additional Information
0 D7 D14 D21 D28 M6
Primary Outcome
Infant crying/fussing time (mins/day) Study diary A validated measure of infant crying/fussing/sleep/feeding and records these behaviours in 5 minute epochs over 24 hours [65-67]. At baseline parents record in the study diary for 24 hours. At other time-points, the diary is filled in over 48 hours. This is to account for daily variability in infant behaviour whilst taking into account the potential burden to families from filling in the diary for prolonged periods of time.
Secondary Outcomes
Infant crying/fussing time (mins/day) Study diary
Number of episodes of crying/fussing/day Study diary
Infant sleep duration (mins/day) Study diary
Maternal mental health scores Edinburgh Postnatal Depression Subscale (EPDS) A 10-item validated questionnaire to screen for depression in the post-partum setting, with higher scores indicating poorer mental health [68]. Scores of ≥10 and ≥12 are validated to detect postnatal depression in community and clinical settings, respectively.
Parent functioning scores PedsQL Family Impact Subscale A 5-item validated questionnaire to assess family functioning, with higher scores indicating better family functioning [69].
Infant functioning scores PedsQL Infant Subscale A 36-item validated questionnaire used to measure infant physical, emotional, social and cognitive functioning [70].
Parent quality adjusted life years scores AQol-4R A 12-item validated questionnaire to assess the health economic parent quality of life [71].
Health service use Additional health professional visits in relation to infant’s crying.
Infant faecal microbiota diversity 16SrDNA amplification (T-RFLP) A molecular method to investigate the diversity within bacterial communities, given as a diversity score, with higher scores indicating more microbial diversity [72].
Infant faecal calprotectin (mg/kg) ELISA An enzyme-linked immunosorbent assay to detect the presence of calprotectin, a marker of gut inflammation [73].
Infant faecal E coli load (cfu/ml) Quantitative PCR A molecular method to detect and measure the presence of particular marker genes of E coli[74].

Sung et al.

Sung et al. BMC Pediatrics 2012 12:135   doi:10.1186/1471-2431-12-135

Open Data