Infantile ColicNCT00860301
Acupuncture in Infantile Colic
A study testing Acupuncture in people with Infantile Colic, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate whether acupuncture influences: the rate of infants who still fulfil the colic criterion after three intervention weeks the time when the infants are crying, fussing or have intense bouts of colicky symptoms Read more about this study
- Who is it for?
- Ages 2 to 8 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2006to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 2-8 weeks old otherwise healthy infants who are fussing/crying more than three hours/day, more than three days during one week
Who cannot join
- infants born before week 36
- infants who dont gain weight properly
- infants taking other medicine than dimethicone or lactobacillus reuteri
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture in Infantile Colic - a Randomised Controlled Double Blind Clinical Study
The purpose of this study is to investigate whether acupuncture influences:
- the rate of infants who still fulfil the colic criterion after three intervention weeks
- the time when the infants are crying, fussing or have intense bouts of colicky symptoms
Read the detailed description
Infantile colic is a common problem. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no known treatment that is both effective and harmless. Acupuncture releases different neurotransmitters and hormones, gives pain reduction and affects digestion. Acupuncture in infantile colic has not been studied in a scientific way even though the method is used in many countries. In this randomised study we will investigate if acupuncture affects symptoms in infantile colic.
- Conditions
- Infantile Colic
- Being tested
- Acupuncture
- Keywords
- infantile colic
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse is alone with the infant for five minutes. Infants in the acupuncture group get acupuncture. One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Not described Receives: Other: Acupuncture |
| Control group | No intervention | Infants come to the clinic six times, are left alone for five minutes with the acupuncture nurse who hold its hand and talks to it. |
What is being measured
The primary outcome is the main question the study is designed to answer.
If the rate of infants who still fulfil the colic criterion in each of the intervention weeks differ between groups.
Measured: First, second and third intervention weeks
Secondary outcomes (1)
If the time when infants are crying, fussing or have intense bouts of colicky symptoms in each of the intervention weeks differ between groups.
Measured: First, second and third intervention weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startDec 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infantile 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
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Ekhagastiftelsen, Magn Bergvalls stiftelse, General Maternity Hospital Foundation
- Investigators
- Inger Hallström, Professor, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860301
- Sponsor's protocol ID
- 1-Landgren
- Status last verified
- Mar 2009
- First submitted
- 11 Mar 2009
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Landgren K.& Hallström I. Akupunkturbehandling vid spädbarnskolik - föräldrars upplevelser av barnets beteende före och efter behandling. Vård i Norden, vol.1, 26-31, 2005.
Landgren K, Kvorning N, Hallstrom I. Feeding, stooling and sleeping patterns in infants with colic--a randomized controlled trial of minimal acupuncture. BMC Complement Altern Med. 2011 Oct 11;11:93. doi: 10.1186/1472-6882-11-93.
PubMed 21989212
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Infantile Colic - a Randomised Controlled Double Blind Clinical Study
- ClinicalTrials.gov ID
- NCT00860301
- Acronym / sponsor ID
- 1-Landgren
- Conditions
- Infantile Colic
- Keywords
- infantile colic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Ekhagastiftelsen, Magn Bergvalls stiftelse, General Maternity Hospital Foundation
- Study start
- Dec 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether acupuncture influences:
- the rate of infants who still fulfil the colic criterion after three intervention weeks
- the time when the infants are crying, fussing or have intense bouts of colicky symptoms
Detailed description
Infantile colic is a common problem. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no known treatment that is both effective and harmless. Acupuncture releases different neurotransmitters and hormones, gives pain reduction and affects digestion. Acupuncture in infantile colic has not been studied in a scientific way even though the method is used in many countries. In this randomised study we will investigate if acupuncture affects symptoms in infantile colic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: Acupuncture |
| Control group | No intervention | –Infants come to the clinic six times, are left alone for five minutes with the acupuncture nurse who hold its hand and talks to it. |
Who may qualify
- Ages
- 2 to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 2-8 weeks old otherwise healthy infants who are fussing/crying more than three hours/day, more than three days during one week
Key exclusion criteria (3 listed)
- infants born before week 36
- infants who dont gain weight properly
- infants taking other medicine than dimethicone or lactobacillus reuteri
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 |
|---|---|---|
| AcupunctureInfants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse is alone with the infant for five minutes. Infants in the acupuncture group get acupuncture. One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn. | Other | Acupuncture group |
Primary outcome
If the rate of infants who still fulfil the colic criterion in each of the intervention weeks differ between groups.
Time frame: First, second and third intervention weeks
1 secondary outcome
If the time when infants are crying, fussing or have intense bouts of colicky symptoms in each of the intervention weeks differ between groups.
Time frame: First, second and third intervention weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
- BackgroundLandgren K.& Hallström I. Akupunkturbehandling vid spädbarnskolik - föräldrars upplevelser av barnets beteende före och efter behandling. Vård i Norden, vol.1, 26-31, 2005.
- Derived from this study: PubMed 21989212Landgren K, Kvorning N, Hallstrom I. Feeding, stooling and sleeping patterns in infants with colic--a randomized controlled trial of minimal acupuncture. BMC Complement Altern Med. 2011 Oct 11;11:93. doi: 10.1186/1472-6882-11-93.
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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.
Inger Hallström, Professor principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Infantile Colic, run by Lund University at 1 site in Sweden.
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 1 inclusion and 3 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 12 Mar 2009. 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 Sweden. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
If the rate of infants who still fulfil the colic criterion in each of the intervention weeks differ between groups. (time frame: First, second and third intervention weeks). 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 NCT00860301, which also lists 2 linked publications.
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 12 Mar 2009.