Intervention Clinical Trial
Official title:
Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children. A Prospective, Randomised, Clinical Trial.
In high-income societies the use of health care and medication is steadily increasing.
Children have high morbidity, many visits at the general practitioner, an increasing number
of hospitalisations, and an increasing use of medication. And, when children are ill,
someone has to stay home to care for them. An un-explained global increase in the incidence
of the allergic diseases eczema, wheezing, asthma and allergies means that 25% of
high-income populations are affected. Cheap preventive measures are highly warranted. Recent
studies have shown a positive, non-specific effect of early Bacille Calmette Guérin (BCG)
immunisation on neonatal mortality in low-income countries and suggested a positive,
non-specific effect on allergic disease in high-income countries. "Non-specific" means that
the vaccine effect goes beyond prevention of the targeted disease, i.e. the BCG vaccine
benefits the health status of the immunised individual in ways unrelated to protection
against tuberculosis (TB). For instance, in a recent randomised trial in West Africa the
investigators showed that the BCG vaccine at birth was safe in low birth weight (LBW)
infants and significantly reduced neonatal mortality in these children, with a significant
long-lasting effect on infant mortality in the smallest newborns with a birth weight <1.5
kg. There is an urgent need to explore the huge potential of the BCG's beneficial
immune-stimulatory effects among children in high-income populations.
Therefore, the investigators will carry out a large prospective randomised clinical trial in
Denmark primarily designed to test the hypothesis that infants who get the BCG vaccine at
birth experience 20% fewer hospitalisations during early childhood.
Secondary outcomes
1. To test the hypothesis that infants who get the BCG vaccine at birth are prescribed
less antibiotics during early childhood than non-BCG-immunised infants.
2. To test the hypothesis that Danish infants who get the BCG vaccine at birth develop
less eczema, asthmatic bronchitis/wheeze and food allergy at 3 and 12 months of age:
self-reported, diagnosed by a physician, or found at clinical examination; and are
prescribed less anti-eczema/asthma/allergy medication during early childhood than
non-BCG-immunised infants.
3. To test the hypothesis that infants who receive the BCG at birth respond in
paraclinical measures: Specific IgE, thymic gland size, leucocyte count and
differentiation, monocyte memory, cytokine profiles, and antibody titres following
immunisation against diphtheria, tetanus, pertussis, pneumococcus, hemophilus.
4. To test the hypothesis that infants who get the BCG vaccine at birth respond in growth
measures: weight, length and head circumference.
5. To test the hypothesis that infants who get the BCG vaccine at birth respond with
decreased morbidity: common cold, pneumonia, febrile episodes, diarrhoea and vomiting,
acute otitis media, febrile convulsions.
6. To test the hypothesis that premature infants with gestational age less than 37 weeks
who get the BCG vaccine at birth have unaffected psychomotor development measures: Ages
and Stages scores.
7. To test the hypothesis that infants who get the BCG vaccine at birth has unaffected
coverage with the subsequent vaccinations in the Child Vaccination Programme.
8. To test the above mentioned hypotheses specifically in the strata of premature and
low-birth-weight Danish infants.
Status | Completed |
Enrollment | 4262 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 7 Days |
Eligibility |
Inclusion Criteria: - All parents planning to give birth at Rigshospitalet, Hvidovre Hospital and Kolding Hospital will receive at letter during 2nd/3rd trimester of pregnancy with information on the study and be offered inclusion in the study. Exclusion Criteria: - Infants born before gestational age 32 weeks and/or birth weight < 1000g, infants with known congenital disease, anomaly or malformation, immune deficiency and HIV, will be excluded. Non-Danish speaking parents will be excluded. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital | Copenhagen | |
Denmark | Rigshospitalet | Copenhagen | Copenhagen Ø |
Denmark | Kolding Sygehus | Kolding |
Lead Sponsor | Collaborator |
---|---|
Lone Graff Stensballe | Danish National Research Foundation, Hvidovre University Hospital, Kolding Sygehus, Research Center for Vitamins and Vaccines (CVIVA) |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Qualitative Research | From qualitative research in focus groups: parents' attitudes and opinions about letting their child BCG vaccinate. "Decisional conflict scale" will be used to score and analyse decisional conflicts for both participants and non-participants. Telephone interview at 3 months of age: The parents' experiences with information given, the vaccination and side effects. From focus group interviews develop and qualify information given to parents before BCG vaccination. "Decisional conflict scale" to score and analyse the parents decisional conflicts for letting the child vaccinate with di-te-ki-pol/Hib. |
0-13 months of age | No |
Other | Communication and Information | To test that the use of telephone and internet will be highly acceptable in this young population. To test scores of information, understanding, competence, and voluntariness. | 0-13 months of age | No |
Primary | All-cause Hospitalisations | To test that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations in early childhood than non-BCG-immunised infants. | 0-15 months of age | No |
Secondary | Antibiotics | To test that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants. | 0-2 years of age | No |
Secondary | Eczema | To test that Danish infants who get the BCG vaccine at birth develop less eczema at 3 and 12 months of age: self-reported, diagnosed by a physician, or found at clinical examination; and are prescribed less anti-eczema medication during early childhood than non-BCG-immunised infants. | 0-13 months of age | No |
Secondary | Specific IgE | To test that infants who receive the BCG at birth respond in specific IgE. | 13 months of age | No |
Secondary | Weight | To test that infants who get the BCG vaccine at birth respond in weight. | 0-13 months of age | No |
Secondary | Psychomotor Development in Premature Infants | To test that premature infants with gestational age less than 37 weeks who get the BCG vaccine at birth have unaffected psychomotor development measures: Ages and Stages scores. | 0-13 months of age | Yes |
Secondary | Vaccination Coverage | To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent vaccinations in the Child Vaccination Programme. | 0-13 months of age | No |
Secondary | Premature Infants | To test the outcome measures specifically in the strata of premature and low-birth-weight Danish infants. | 0-2 years of age | No |
Secondary | Asthma | To test that Danish infants who get the BCG vaccine at birth develop less asthma at 3 and 12 months of age: self-reported, diagnosed by a physician, or found at clinical examination; and are prescribed less anti-asthma medication during early childhood than non-BCG-immunised infants. | 0-13 months | No |
Secondary | Food Allergy | To test that Danish infants who get the BCG vaccine at birth develop less food allergy at 3 and 12 months of age: self-reported, diagnosed by a physician, or found at clinical examination; and are prescribed less anti-allergy medication during early childhood than non-BCG-immunised infants. | 0-13 months | No |
Secondary | Length | To test that infants who get the BCG vaccine at birth respond in length. | 0-13months | No |
Secondary | Head Circumference | To test that infants who get the BCG vaccine at birth respond in head circumference. | 0-13months | No |
Secondary | Thymic Gland Size | To test that infants who receive the BCG at birth respond in thymic gland size. | 0-13 months of age | No |
Secondary | Leucocyte Count and Differentiation | To test that infants who receive the BCG at birth respond in leucocyte count and differentiation. | 0-13 months of age | No |
Secondary | Monocyte Memory | To test that infants who receive the BCG at birth respond in monocyte memory. | 0-13 months of age | No |
Secondary | Cytokine Profiles | To test that infants who receive the BCG at birth respond in cytokine profiles. | 0-13 months of age | No |
Secondary | Antibody Titres Following Immunisation Against Diphtheria, Tetanus, Pertussis, Pneumococcus, Hemophilus | To test that infants who receive the BCG at birth respond in antibody titres following immunisation against diphtheria, tetanus, pertussis, pneumococcus, and haemophilus. | 0-13 months of age | No |
Secondary | Common Cold | To test that Danish infants who get the BCG vaccine at birth develop less common cold at 3 and 13 months of age than non-BCG-immunised infants. | 0-13 months of age | No |
Secondary | Pneumonia | To test that Danish infants who get the BCG vaccine at birth develop less pneumonia at 3 and 13 months of age than non-BCG-immunised infants. | 0-13 months of age | No |
Secondary | Febrile Episodes | To test that Danish infants who get the BCG vaccine at birth develop less febrile episodes at 3 and 13 months of age than non-BCG-immunised infants. | 0-13 months of age | No |
Secondary | Episodes With Diarrhoea and Vomiting | To test that Danish infants who get the BCG vaccine at birth develop less episodes with diarrhoea and vomiting at 3 and 13 months of age than non-BCG-immunised infants. | 0-13 months of age | No |
Secondary | Acute Otitis Media | To test that Danish infants who get the BCG vaccine at birth develop less acute otitis media at 3 and 13 months of age than non-BCG-immunised infants. | 0-13 months of age | No |
Secondary | Febrile Convulsions | To test that Danish infants who get the BCG vaccine at birth develop less febrile convulsions at 3 and 13 months of age than non-BCG-immunised infants. | 0-13 months of age | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05193773 -
Effects of a Multifactorial Intervention to Reduce Physical Restraints for Care Providers in Nursing Homes
|
N/A | |
Completed |
NCT03253406 -
Health Wearables and College Student Health
|
N/A | |
Completed |
NCT04428034 -
Learning Skills Together Pilot Study
|
N/A | |
Recruiting |
NCT00546845 -
Balloon Angioplasty Versus Xpert Stent in CLI Patients XXS Study
|
Phase 4 | |
Not yet recruiting |
NCT06326151 -
Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults
|
N/A | |
Recruiting |
NCT01979627 -
Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty
|
N/A | |
Active, not recruiting |
NCT03648593 -
Promo@Work Entrepreneurs
|
N/A | |
Completed |
NCT04418687 -
Use of the Orthoglide for Improved Patient Outcome Following Total Knee Replacement
|
N/A | |
Recruiting |
NCT05380050 -
Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD
|
N/A | |
Recruiting |
NCT04953819 -
Coronary Revascularization in Patients With Dialysis in China
|
||
Recruiting |
NCT05820646 -
Effect of Boswellia Sacra as an Intracanal Medicament on Postoperative Pain Intensity and Bacterial Load Reduction
|
N/A | |
Completed |
NCT03118167 -
Intervention Effect of TP and AOB-w on Acrylamide Exposure in Chinese Adolescents
|
N/A | |
Recruiting |
NCT05091957 -
Connecting Families
|
N/A | |
Completed |
NCT05500781 -
Online Program for Coaching Girls: Coaching HER
|
N/A | |
Completed |
NCT05316558 -
Web-Based Body Image Intervention for Coaches of Adolescent Girls - Pilot
|
N/A | |
Completed |
NCT04608370 -
Transcranial Photobiomodulation Intervention for Healthy Older Adults
|
N/A | |
Recruiting |
NCT06026904 -
The Effects of taVNS on Motivation in MDD With Anhedonia
|
N/A | |
Enrolling by invitation |
NCT06198491 -
Evaluation of Educational Interventions Targeting Beliefs About Human Papillomavirus (HPV)
|
N/A | |
Active, not recruiting |
NCT05426863 -
Domestic Violence Intervention to Reduce Psychological Distress and Violence Among Women Experiencing IPV in Nepal
|
N/A | |
Terminated |
NCT02991430 -
A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
|
N/A |