ColicNCT00796523

An Intervention to Decrease Infant Crying

A study testing Happiest Baby videotape in people with Colic, run by Riverside Methodist Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a study looking at the Happiest Baby on the Block technique. The investigators hypothesized that infants of mothers given a 30 minute videotape demonstrating the Happiest Baby on the Block technique would fuss/cry less and sleep longer than infants of mothers given a 30 minute videotape on general newborn… Read more about this study

Who is it for?: Ages Up to 5 daysHealthy volunteers can take part
Conditions the study is for: Colic
What is being tested?: Happiest Baby videotape
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Aug 2005to May 2006
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 5 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Mothers of singleton newborns
37 to 41 week gestation
healthy (no ICU admission)

Who cannot join

not able to view videotape at home
not able to speak English

Trial locations and contacts

1 site in 1 country.

United States1 site

Riverside Methodist Hospital
Columbus, Ohio, 43214

Other trials in United States

About this study

Official title: A Randomized, Controlled Trial to Decrease Infant Crying

Read the detailed description

Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.

Conditions: Colic
Being tested: Happiest Baby videotape, control videotape
Keywords: colic, crying, clinical trial
Medical subject headings: Colic, Crying

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Happiest Baby videotapeBehavioural
Also called Happiest Baby on the Block technique
a videotape demonstrating the Happiest Baby on the Block technique for calming crying infants
control videotapeBehavioural
Also called Civitas' Begin with Love
a videotape with general newborn care instructions

Study groups in NCT00796523
Study group	Role	What they receive
Happiest Baby videotape	Experimental	videotape describing the Happiest Baby on the Block technique Receives: Behavioral: Happiest Baby videotape
control videotape	Placebo comparator	videotape with normal newborn instruction Receives: Behavioral: control videotape

What is being measured

The primary outcome is the main question the study is designed to answer.

Hours Per Day of Fuss/Cry
total hours per day of fuss, cry, and unsoothable crying.
Measured: week 8
Hours Per Day of Sleep
mean sleep time is the mean of 3 daily sleep times reported in a time period.
Measured: week 8

Secondary outcomes (1)

Parenting Stress Index
a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.
Measured: week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2005May 2006

First posted24 Nov 2008 (estimated)
Study startAug 2005
Primary completionFeb 2006
Study completionMay 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ColicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00796523
Sponsor's protocol ID: 941
Status last verified: Nov 2008
First submitted: 16 Oct 2008
Last updated: 24 Nov 2008
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Effect of Probiotics in Infantile Colic
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Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
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RELIEF-pathway in Patients With Upper Abdominal Pain
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Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
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All Colic trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Trial to Decrease Infant Crying
ClinicalTrials.gov ID: NCT00796523
Acronym / sponsor ID: 941
Conditions: Colic
Keywords: colic, crying, clinical trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Riverside Methodist HospitalUniversity, hospital or other
Collaborators: Prevent Child Abuse America
Study start: Aug 2005
Primary completion: Feb 2006 (actual)
Study completion: May 2006 (actual)
First posted: 24 Nov 2008 (estimated)
Results: Posted 24 Nov 2008

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Happiest Baby videotape	Experimental	Behavioral: Happiest Baby videotapevideotape describing the Happiest Baby on the Block technique
control videotape	Placebo comparator	Behavioral: control videotapevideotape with normal newborn instruction

Who may qualify

Ages: Up to 5 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Mothers of singleton newborns
37 to 41 week gestation
healthy (no ICU admission)

Key exclusion criteria (2 listed)

not able to view videotape at home
not able to speak English

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Happiest Baby videotapeAlso: Happiest Baby on the Block techniquea videotape demonstrating the Happiest Baby on the Block technique for calming crying infants	Behavioural	Happiest Baby videotape
control videotapeAlso: Civitas' Begin with Lovea videotape with general newborn care instructions	Behavioural	control videotape

Primary outcome

Hours Per Day of Fuss/Cry
Time frame: week 8
total hours per day of fuss, cry, and unsoothable crying.
Hours Per Day of Sleep
Time frame: week 8
mean sleep time is the mean of 3 daily sleep times reported in a time period.

1 secondary outcome

Parenting Stress Index
Time frame: week 6

Results and safety

Results posted to the registry on 24 Nov 2008, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Happiest Baby Videotape	27	18
Control Videotape	24	17

Primary outcome: Hours Per Day of Fuss/Cry

Time frame: week 8. Mean (Standard Deviation). Unit: hours per day

Measure	Happiest Baby Videotape n = 18	Control Videotape n = 17
Value	2.20 (1.25)	1.48 (1.23)

Population analysed: If fewer than 3 diaries were completed for a given time period (that is, one or two of the days was missing or had more than 180 minutes unrecorded), then the average of only the completed diaries was used. Results are based on ITT; 16 subjects did not complete any diaries and are not included in the analysis

Primary outcome: Hours Per Day of Sleep

Time frame: week 8. Mean (Standard Deviation). Unit: hours per day

Measure	Happiest Baby Videotape n = 18	Control Videotape n = 17
Value	13.87 (1.60)	14.1 (1.73)

Population analysed: Results based on ITT; 16 subjects did not complete any diaries and are not included in the analysis

1 secondary outcome is reported in the full results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2008.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Colic

Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Rectal Cancer, Colon Cancer
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
Recruiting
Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
Infant Colic, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonna M. McRury, M.D. principal investigator

University of Toledo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Happiest Baby videotape in people with Colic, run by Riverside Methodist Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hours Per Day of Fuss/Cry (time frame: week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00796523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2008.