Table 1.
Outcome measures (adapted from Sung et al34)
| Outcomes | Days | Month 6 | Measure | Additional information | ||||
|---|---|---|---|---|---|---|---|---|
| 0 | 7 | 14 | 21 | 28 | ||||
| Primary outcome: | ||||||||
| Daily cry/fuss time (min/day) | — | — | — | — | Y | — | Baby’s Day Diary | Validated measure of infant crying, fussing, sleep, and feeding. Records these behaviours in 5 minute epochs over 24 hours.35 At baseline, parents record in study diary for 24 hours. At other time points, diary filled in over 48 hours (to reduce daily variability in infant behaviour while taking into account potential burden to families from filling in diary for prolonged periods) |
| Secondary outcomes: | ||||||||
| Daily cry/fuss time (min/day) | Y | Y | Y | Y | — | Y | Baby’s Day Diary | |
| Daily cry/fuss episodes | Y | Y | Y | Y | Y | Y | Baby’s Day Diary | |
| Infant sleep duration (min/day) | Y | Y | Y | Y | Y | Y | Baby’s Day Diary | |
| Maternal mental health scores | Y | — | — | — | Y | Y | Edinburgh postnatal depression subscale | 10 item validated questionnaire to screen for depression in postpartum period, with higher scores indicating poorer mental health.37 Scores validated to detect postnatal depression in community (≥10) and clinical (≥12) settings |
| Infant functioning scores | — | — | — | — | — | Y | Paediatric quality of life inventory infant subscale | 36 item validated questionnaire to measure infant physical, emotional, social, and cognitive functioning38 |
| Family functioning scores | Y | — | — | — | Y | Y | Paediatric quality of life inventory family impact subscale | 5 item validated questionnaire to assess family functioning, with higher scores indicating better family functioning39 |
| Parent quality adjusted life years scores | Y | — | — | — | Y | Y | Assessment of quality of life (AQol-4R) | 12 item validated questionnaire to assess health economic parent quality of life40 |
| Infant faecal microbial diversity* | Y | — | — | — | Y | — | 16SrDNA amplification (T-RFLP) | Terminal restriction fragment length polymorphism, a molecular method to investigate diversity within bacterial communities, given as diversity score, with higher scores indicating more microbial diversity41 |
| Infant faecal Escherichia coli colonisation(cfu/mL)* | Y | — | — | — | Y | — | Quantitative polymerase chain reaction | Molecular method to detect and measure presence of a marker gene of E coli42 |
| Infant faecal calprotectin (mg/kg)† | Y | — | — | — | Y | — | Enzyme linked immunosorbent assay | To detect presence of calprotectin, a marker of gut inflammation43 |
cfu=colony forming units.
*Funding allowed analysis of a subset of faecal samples collected at one month post-intervention only.
†Funding allowed analysis of first 102 faecal samples collected at one month post-intervention only.