1 group of subjects will all receive the high antioxidant cacao bars. 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m.

Autism Spectrum Disorder

Dark Chocolate bars with 70% cacao and 30% organic cane sugar where 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m. daily for four weeks.

Dark Chocolate

Loma Linda University Health

The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder

This is a valid and reliable tool that is made up of 58 questions comprised of 5 main content areas: Irritiability, agitation, crying; Lethargy and Social Withdrawal; Stereotypic Behavior, Hyperactivity Non Compliance, and Inappropriate Speech.

A valid and reliable tool with 71 items and each item is ranked with scores from 0 to 4 with 0 meaning the behavior never happens and 4 means it happens very frequently. This rating scale asks questions related to play skills, social interaction skills, communication skills, rigid behaviors, and understanding of humor.

Designed to evaluate the magnitude of stress in the parent-child system, with 120 questions that focus on three major domains of stress: child characteristics, parent characteristics, and situational/demographic life stress.

Loma Linda University

These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.

Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.

Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.
Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m

Integrated Protocol

These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.
Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.

Current Protocol

Total

Sex: Female, Male

Region of Enrollment

Midupper arm circumference

Recovery by the end of treatment standard protocol will be compared to the integrated protocol. Recovery will be defined as mid upper arm circumference (MUAC) reaching ≥12.5 cm.
Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed.

Recovery Under the Integrated Program and the Standard Protocol

Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Measurement is taken at each visit but final recovery measurement will be used.

Change in Growth Rates

Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Time to achieve MUAC of 12.5 cm will be documented.

Duration of Treatment

Any changes in recovery will be measured 6 months at follow-up visit. Number of children still well nourished.

Change in Recovery Status After 12 Weeks

Overall Study

Mark Manary

Malnutrition

Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 months. Caretakers will be instructed to seek medical care sooner if the child has fever, poor appetite or signs of an acute illness.

Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.

Current protocol

Ethiopia Federal Ministry of Health. Protocol for the Management of Severe Acute Malnutrition. 2007

Measuring the effectiveness of Supplementary Feeding Programmes in emergencies. Humanitarian Practice Network. 2008

The Sphere Project. The Sphere Project - Humanitarian Charter and Minimum Standards in Humanitarian Response. 2011

Infant and young child feeding in emergencies (IFE) Core Group. Complementary Feeding of Infants and Young Children in Emergencies. 2009

. USAID and World Relief. Tube Poka Child Survival Project Final Evaluation Report

USAID and Medical Teams International. Grant Cape Mount Child Survival Program - Improved Child Health in a Transitional State through IMCI. Final Evaluation Report. 2011

GOAL and USAID. GOAL ETHIOPIA: Sidama Child Survival Program MID-TERM EVALUATION REPORT Awassa Zuria and Boricha Woredas of the Southern Nations, Nationalities, and Peoples (SNNP) Region of Ethiopia. 2009

Anon. The U.S. President's Emergency Plan for AIDS Relief

World Health Organization and UNICEF. Integrated Management of Childhood Illness (IMCI) Handbook. Geneva; 2005

World Health Organization, World Food Programme, United Nations Standing Committee on Nutrition and United Nations Children's Fund. Community-Based Management of Severe Acute Malnutrition. 2007

Project Peanut Butter Factory - 41D Wilkinson Road

Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone

Conducting Research on Moderate Acute Malnutrition in Humanitarian Emergencies Integrated Management of MAM and SAM in Sierra Leone With Ready to Use Theraputic Foods (RUTF)

Washington University School of Medicine

Children born to mothers, who have accepted to participate, will be randomised to either intervention group or to the control group at birth. Block-randomisation stratified by hospital, gender and gestational age (≥37 weeks of gestation vs. < 37 weeks of gestation) will be performed electronically just before vaccination by the overall study electronic case report system (e-crf).
Children randomised to the BCG vaccination group will receive an intradermal BCG vaccine (Statens Serum Institute "CG vaccine" in the standard dose 0.05 ml in the upper, lateral part of the arm of the child by a specially trained midwife or a study physician.

Control children will be treated as usual, since no suitable placebo exists.

BCG-vaccine

Control Children

Gender of the child. In multiple births: gender of the first born child.

All three study sites are situated in Denmark.

Premature birth

To test that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations in early childhood than non-BCG-immunised infants.

Control Children (no Intervention)

All-cause Hospitalisations

To test that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants. Use of antibiotics was defined as one or more precriptions of systemic antibiotics (ATC groups J01, J02, J05, all subgroups inclusive).

Antibiotics

To test if BCG vaccination within 7 days after birth influence the risk of atopic dermatitis defined by clinical examination at 13 months of age using "scoring atopic dermatitis (SCORAD)" or by parental report of physician diagnosed atopic dermatitis in the telephone interview at 13 months of age.

Atopic Dermatitis

Number of participants with specific IgE (Phadiatop Infant) above the clinical cut-of level of 0.35.

Specific IgE

To test that infants who get the BCG vaccine at birth respond in weight.The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Standardized Weight at 13 Months

To test that premature infants with gestational age less than 37 weeks who get the BCG vaccine at birth have unaffected psychomotor development measures: ASQ: Ages and stages questionnaire - a parent reported questionnaire that measures child psychomotor development. Total range of ASQ score: 0 to 300 points. Higher scores indicate higher level of psychomotor development.

Psychomotor Development in Premature Infants

To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent 3rd diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b (DTaP-IPV-Hib) vaccination scheduled to 12 months of age according to the Danish child vaccination programme. Since we did not expect all children to get their immunizations exactly at 12 months of age, the children were followed up until 13-months of age.

DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age

The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Standardized Weight, Length and Head Circumference of Premature Children at 13 Months

Number of participants diagnosed with episodic viral wheeze by a physician and treated with anti-asthmatic medicine according to the telephone interview.

Episodic Viral Wheeze

Number of participants with food allergy diagnosed by a physician and mentioned in the telephone interview at 13 months of age

Food Allergy

To test if infants who get the BCG vaccine at birth respond in length. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Length at 13 Months of Age

To test if infants who get the BCG vaccine at birth respond in head circumference. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Standardized Head Circumference at 13 Months of Age

To test that infants who receive the BCG at birth respond in thymic gland size defined by ultra sound examination. First, the thymus gland was identified in a horizontal scanning plane and the largest transverse diameter of the thymus was obtained. Second, in a sagittal scanning plane, the area of the largest lobe was assessed. Both measurements were obtained twice, and in case of more than 15% difference, both measurements were repeated. The mean of the two measurements were multiplied and defined as the thymic index.

Thymic Gland Size at 3 Months of Age

To test if infants who receive the BCG at birth respond in leucocyte count (white blood cell count) measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).

Leucocyte Count 4 Days After Randomisation/Vaccination

To test if infants who receive the BCG at birth respond in monocyte count measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).

Monocyte Count 4 Days After Randomisation/Vaccination

To test that infants who receive the BCG at birth respond in interferon-gamma response upon stimulation with BCG. The interferon gamma response was defined as a value above the cut-off value of 107 pg/ml.

Interferon Gamma Response

To test the tetenus antibody response in BCG-vaccinated vs. non-BCG vaccinated children following routine immunisation against tetanus at 3, 5 and 12 months of age in blood samples obtained 13 months of age.

Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL

To test that Danish infants who get the BCG vaccine at birth experience less events of common cold until 13 months of age than non-BCG-immunised infants.

Number of Events of Common Cold

To test that Danish infants who get the BCG vaccine at birth get less pneumonia at 13 months of age than non-BCG-immunised infants.

Number of Events of Pneumonia

To test that Danish infants who get the BCG vaccine at birth get less febrile episodes at 13 months of age than non-BCG-immunised infants.

Number of Events of Febrile Episodes

To test that Danish infants who get the BCG vaccine at birth develop less episodes with diarrhoea and vomiting at 13 months of age than non-BCG-immunised infants.

Number of Events With Diarrhoea and Vomiting

To test that Danish infants who get the BCG vaccine at birth develop less acute otitis media at 13 months of age than non-BCG-immunised infants.

Number of Events of Acute Otitis Media

To test that Danish infants who get the BCG vaccine at birth develop less febrile convulsions at 13 months of age than non-BCG-immunised infants.

Number of Events of Febrile Convulsions

After parents having made the decision about whether to accept vaccination of their newborn through participation in The Danish Calmette Study, O'Connor's Decisional Conflict Scale was used to identify decisional conflicts. The score ranges from 0 (no decisional conflict) til 100 (maximum decisional conflict). Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation; so a low score reflects a low level of doubt about the decision about participation/decline participation in the trial, and a high score reflects a high level of doubt.

Mothers who decided to let their child participate in the study

Participating Mothers

Mothers who decided not to let their child participate in the study

Declining Mothers

Decisional Conflict Scale Score

To test that the use of telephone and internet was acceptable in the study population using the Quality of Informed Consent (QuIC) questionnaire. The questionnaire was divided into six categories; five on study comprehension and one on satisfaction with the information process. The items in the first five categories could be answered with "yes", "no" or "do not know". The last category was rated on a 7-point Likert scale, with 1 being "very dissatisfied" and 7 being "very satisfied". The primary outcome was the sum of the score for comprehension items and satisfaction items. Comprehension items were scored 1 point for each correct answer and 0 points for each incorrect answer. Satisfaction items were scored as rated on the 7-point Likert scale. Total score ranged from 7 to 69 points, comprehension score from 0 to 20 points and satisfaction score from 7 to 49 points. The higher score, the better comprehension and satisfaction.

Randomized to receive information about the study by telephone

Telephone

Randomized to receive information about the study by standard face-to-face consultation.

food hypersensitivity/seizures

The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder

Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone

Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.

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