Infantile Colic

1. Vestibular stimulation with Indian Hammock
versus Music therapy in prevention &
management of Infantile colic in term infants: a
prospective, open labelled randomized
controlled trial
Investigator : Dr.Ravi Kumar S
Guide: Dr.Gunasekaran D, Dept of Pediatrics
Co-Guide : Dr.Srinivasa Raghavan R, Dept of
Pediatrics
Co-Guide : Dr.Sumathy Sundar, Dept of Music
Title

2. Introduction
Infantile colic : Commonest cause in the first 4
months of life, to seek medical attention
 Though Self limiting & Benign, causes extreme
anxiety & maternal depression
 Definition: Rome IV Criteria (2016)- Fussing or
crying without obvious causes, for ≥3 hours a
day and occur ≥3 days a week for ≥1 week in
infants from birth to 5 months of age
 Incidence : 10% to 40% of infants worldwide

3. Review of Literature
Pathogenesis : Exact etiology is not known, suggested
hypothesis are Gut microflora alterations, painful gut
contractions, lactose intolerance, passage of gas, or
parental misinterpretation of normal crying.
Various treatment options tried-
 Parental reassurance/ Probiotics like Lactobacillus
reuteri/ Dietary Modifications (low allergen maternal
diet, hydrolysed formulas) / Drugs such as
Simethicone, PPI/ Herbal Supplements/ Acupuncture/
Massage.

4. Justification of the Study
 No definite treatment recommended till date
despite this condition being, a distressing one
 Traditionally in south India- Indian Hammock
(Thooli) and lullabies have been used by
generations of people to console the crying infant
in India their effects on prevention and
management of Infantile colic has not been
studied
 Results of the study might be helpful in devising
an economical and a culturally acceptable

5. Research Question
 Is Vestibular stimulation offered by the
Indian hammock(Thooli) or music therapy
effective in prevention and management of
infantile colic in infants born at Term ?

6. Aims
 To evaluate the efficacy of Vestibular stimulation by
Indian Hammock/ “Thooli” in prevention and
management of infantile colic
 To evaluate the efficacy of Music Therapy in
prevention and management of infantile colic
 To compare the efficacy of vestibular stimulation by
Indian hammock with music therapy in prevention &
management of infantile colic

7. Objectives
 Primary: To compare the incidence if Infantile colic
over a 4 month follow-up in term neonates- one
group receiving music therapy and one group
receiving vestibular stimulation with a control group
 Secondary:
1. To study the various cultural practices/ home
remedies that are followed if a child develops
infantile colic
2. To compare the rates of Exclusive Breast feeding
among mothers in the three groups.

8. Methods
Type of Study : Prospective RCT
Place of Study : Department of Paediatrics, MGMCRI.
Study Population : 435 term neonates
Sample Size : Using OpenEpi software version 3.01
Alpha error of 5% & Power of 80%
Prevalence of 30% (Based on existing data)
Expecting - the interventions would reduce the prevalence by 50%
The sample size in each group was calculated to be 121.
Since a follow up period of four months is planned, an attrition of
20% is expected.
Hence the final sample size was computed to be 145 in each group
(total of 435 neonates to be recruited and randomized into three
groups).

9. Selection Criteria
 Inclusion criteria
All term neonates (completed 37 weeks of gestation),
delivered in our hospital.
 Exclusion criteria
-Term babies with Birth weight <1500g
-Term babies who are sick due to any cause (Birth
injuries, Respiratory distress syndrome, Neonatal
seizures due to any cause, Perinatal asphyxia,
Neonatal hypoglycemia, Neonatal sepsis,
Hyperbilirubinemia requiring exchange transfusion)

10. Interventions- Common for both
treatment groups
 Every mothers of the infants participating in the
study will be given information about Infantile colic,
harmful practices & the common misconceptions
among the caretakers.
 Video clippings (will be shown if necessary)
 Day and night routine establishment emphasized

11. Interventions
Group A: The Indian Hammock/ Thooli group
• Pictures of the Indian hammock would be
shown
• Parents are instructed to start using Thooli from
2 weeks of age
• Advised to put the baby to sleep inside the
hammock and swing him gently in a to-and-fro
motion till the infant sleeps- no specific duration
will be mentioned
• Parents are instructed to keep the wooden
piece to separate both the limbs of Thooli to
provide adequate ventilation- avoid prone
position; avoid swaddling
• Parents are instructed to note the log of cry
events and number of hours the baby was put

12. Indian Hammock

13. Interventions
Group B: Music group
• Soft soothing instrumental music/ lullabies in the
vernacular language recorded on a CD/File will be
provided to all mothers of the infants included in the
study
• To be used daily from birth till 4 months of age.
• Encouraged to play the music for a cumulative duration
of at least 4 hours a day with one stretch of at least 1
hour
• The devices used to play music must be CD player/ any
cell phone with Bluetooth capability/ Tablet/ Laptop.
• Parents are instructed to bring any of these devices to
assess the sound using digital sound level meter/
Sound meter app so that the loudness will not exceed
80 dB which is to be placed 30 cm away from the baby.
• Parents are instructed to maintain the log of cry

14. Interventions
Group C: Control group
• No specific interventions planned at birth
• On follow up- if colic develops, parental
counselling and support would be given to the
parents- existing standard of care
• In case any harmful measures followed- advice
to discontinue the same would be given- Gripe
water, massage manoeuvres, drugs etc.
• If parents initiated Thooli or Music for their baby,
then its duration of exposure to the intervention
would be noted.

15. Follow up
 Three visits- planned to coincide with vaccine visits
 For all the groups- To improve compliance for
maintaining log of events and for follow up- dedicated
phone number to be used by study team- parents will
be called 2 weekly in the first 2 months and then
once a month
 During the calls- advice to continue the interventions
would be given

16. CONSORT diagram
TERM NEONATES DELIVERED AT MGMCRI DURING THE STUDY PERIOD
Excluded(n=)Not meeting
inclusion criteria
(n=),Declined to participate
(n=)
Randomized (n=)
Group A
Indian Hammock (n=)
Group B
Music Therapy (n=)
Group C
Control ,Existing norms(n=)
Lost to Follow-up (n=) Lost to Follow-up (n=)
Lost to follow-up (n=)
Analysis (n=), Excluded from analysis (n=) (reason)

17. Statistical Methods
Outcome :
• Main outcome variable is proportion of infants who
develop infantile colic (Rome IV Criteria) in each of the
three groups.
S.No Dependent Variables Nature Methods Used
1 Proportion of infants who
develop infantile colic
Quantitative Mean & SD
2 Mean duration of crying spells
in hours
Quantitative Mean & SD
3 Mean number of colic
Episodes
Quantitative Mean & SD
4 Proportion of mothers who
continued exclusive breast
feeding
Quantitative Mean & SD

18. Ethical Issues
 Thooli and music therapy- both are innocuous
interventions- no foreseeable risks
 Both- neuro-developmental advantages- routinely
used in many infant stimulation protocols
 Neonates are included in the study only if their
parents are giving written consent.
 Personal details will be anonymized.
 Follow-up visits will be linked with vaccination visits-
no extra visits

19. So Far,..
 Recruitment was completed on
28/04/18
 Follow-up: (257/435)
 Group A : 91/145 –63%
 Group B : 54/145 – 37%
 Group C : 112/145 – 77%
 Satisfies Colic Criteria – 26
 Incessant Cry not amounting IC – 31