Skip to main content
. 2019 Dec 3;2019(12):CD012459. doi: 10.1002/14651858.CD012459.pub2

Saeidi 2013.

Methods Study design: randomised controlled trial of kangaroo care vs conventional care
 Location: Iran
 Setting: recruitment at Sheikh Children Hospital Clinic but intervention applied at home
Participants Sample size: 70 infants
 Number of dropouts/withdrawals: 22 infants
 Mean age: 7.2 weeks (SD = 2.3)
 Inclusion criteria:
  1. infantile colic based on modified Wessel criteria

  2. aged between 3 and 12 weeks

  3. breast fed

  4. first born

  5. born at term

  6. weighed more than 2500 grams

  7. had uncomplicated pre‐ and post‐natal course


Exclusion criteria
Infant:
  1. formula fed

  2. congenital abnormalities

  3. intrauterine growth reduction

  4. premature birth

  5. low birth weight

  6. low APGAR

  7. fed poorly

  8. vomited

  9. constipated


Mother:
  1. illness

  2. addiction

  3. hypertension

  4. pre‐eclampsia

  5. diabetes

  6. prolonged labour

Interventions Intervention group (n = 25): parents instructed to provide kangaroo care for 2 hours a day
 Control group (n = 23): parents asked to "shaking the baby in the crib" (quote). No further clarification was given on this, although the authors do clearly elicit in their discussion that this standard care was in no way comparable to other forms of shaking that the word may infer. So as not to confuse readers, we use the word 'rocking' (or 'rock') in the text. 
 Duration of intervention: 9 days
Outcomes Primary outcome: crying time
  1. Intervention group: mean crying time at baseline = 3.5 hours per day; mean crying time after 7 days = 1.7 hours per day

  2. Control group: mean crying time at baseline = 3.5 hours per day; mean crying time after 7 days = 3 hours per day


The difference was statistically significant (P < 0.05).
Secondary outcome: infant sleep, measured by parental diaries.
  1. Intervention group: mean sleep duration at baseline = 8.3 hours per day; mean sleep duration after 7 days = 12 hours per day

  2. Control group: mean sleep duration at baseline = 8 hours per day; mean sleep duration after 7 days = 9 hours per day


The difference in sleep duration when comparing the kangaroo group to the control group over 7 days of treatment was significant (P = 0.02).
No standard deviation values were provided.
Notes Study start date: May 2008
 Study end date: May 2009
 Declared DOI: none stated
 Perceived DOI: none perceived
 Funding source: none stated
Other comments: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: states participants were randomised but does not describe how this was done and no response from request from author
Allocation concealment (selection bias) Unclear risk Comment: not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: researcher aware of personnel in each study arm
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: parents recorded crying times in diaries
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: 22 (out of 70) infants dropped out and were excluded from analysis. Reasons for dropout included mothers being unwell, being too busy or "difficulty in regularly completing the diaries" (quote)
Selective reporting (reporting bias) Low risk Comment: all outcomes reported
Other bias Low risk Comment: none apparent