Identification

• Cohort, name
  German Infant Study on the influence of Nutrition Intervention
  
  Cohort, abbreviation
  GINIplus
  
  Cohort, country
  Germany (Deutschland)
  
  Cohort, website
  http://www.ginistudie.de/
  
  Key reference
  von,Berg A.; Koletzko,S.; Grubl,A.; Filipiak-Pittroff,B.; Wichmann,H.E.; Bauer,C.P.; Reinhardt,D.; Berdel,D. The effect of hydrolyzed cows milk formula… J Allergy Clin Immunol. 2003 Mar;111(3):533-40. Laubereau B et al. Effect of breast-feeding…J Pediatr, 2004; 144:602-7
  
  Date of filling in this questionnaire:
  2011-09-28
  
  
• Principal investigator(s), name
  D. Berdel; A.v. Berg; B. Hoffmann; C.P. Bauer; S. Koletzko; J. Heinrich
  
  Principal investigator(s), e-mail address
  heinrich@helmholtz-muenchen.de
  
  Principal investigator(s), institution
  HelmholtzZentrum München
  
  

Basic description

• Main aim of cohort
  Intervention substudy; double blinded randomized trial for hypoallergenic formulae, observational substudy: natural course of atopic diseases and metabolic disorders; mental health, nutrition, body weight and physical activity;
  
  Recruited number of:
  5991 children / 0 mothers / 0 fathers / 0 grand parents / 0 other family members
  
  Approximate proportion of source population included
  0
  
  Source population
  Region-based
  
  
• Period of enrollment
  Start: 1995-01-01, End: 1998-01-01
  
  Enrollment period
  At birth  to
  
  Enrollment criteria, please specify
  Healthy term newborns
  
  Exclusion criteria, please specify
  LBW, insufficient German language skills
  
  Planned age of children at end of follow-up
  Life-long / unrestricted

Questionnaire or registry data and biological samples

• Children
• Mothers
• Fathers

General information	---------- Child age (years) at assessment ----------
	<1	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	>18
Home address
School address

Birth outcomes
Birth weight	X
Birth length	X
Gestational age at birth	X
Apgar score
Congenital malformations
Stillbirth (>= 22 weeks)
Child’s sex
Head circumference
Biparietal diameter

Child exposures	---------- Child age (years) at assessment ----------
	<1	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	>18
Breast feeding	X	X	X
Diet											X					X
Dietary supplements
Childcare attendance		X	X	X	X		X
Active smoking																X
Passive smoking	X	X	X	X	X		X				X					X
Alcohol consumption																X
Physical activity											X					X
Substance use
Medicine intake											X					X
Vaccinations	X
Psychological distress (e.g. bullying)
Air pollution
Access to green spaces
Built environment
Noise
Radiation, electromagnetic fields
Water contamination
Pets
Farm animal exposure
Biomarkers of exposure
Mercury
Lead
Cadmium
Arsenic
Other metals
Polychlorinated biphenyl esters
Dicloro difenil tricloroetano
Hexachlorobenzene
Brominated flame retardants
Perflouralkyl compounds
Bisphenol A
Other bisphenols
Parabens
Benzophenones
Triclosan
Phthalates
Cotinine

Child development and health	---------- Child age (years) at assessment ----------
	<1	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	>18
Anthropometry
Weight	X						X				X					X
Height	X						X				X					X
Head circumference
Abdominal circumference
Arm circumference
Wrist circumference
Waist circumference
Clinical examinations
Blood pressure		X		X			X				X					X
Carotida intima media thickness
Pulse wave velocity
Cardiac ultrasound
Renal ultrasound
Brain MRI
Other MRI
DEXA‐scan results
Skin folds
Bio impedence
Oscilometry
Spirometry
Skin prick test
Bronchial challenge test
Reversibility test
Dental observations
Mental and neurological development
Cognitive function
School performance											X					X
Language
ADHD
Autism
Sleep disturbances																X
Mental health											X					X
Respiratory health
Asthma
Allergy
Allergic rhinitis
Eczema
Respiratory tract infections
Senses
Vision
Hearing
Musculo-skeletal health
Back pain
Neck pain
Growing pains
Sexual maturation
Tanner stage
Pubertal development stage
Age at menarche
Age at voice change
2D/4D digit ratio
Nocturnal ejaculation
Acne
Other health outcomes
Cancer
Diabetes											X					X
Congenital anomalies
Biomarkers of health
Nephrology (e.g. creatinine, albumin)
Thyroid hormones
Inflammatory markers (e.g. C-reactive protein cytokines)
Immunologic markers (e.g. immunoglobulines)
Cortisol
Vitamines and micronutrients
Gonadal axis hormones (e.g. testosterone, estradiol)
Metabolism (e.g. cholesterol, LDL, HDL, insulin, triglycerides)
Metabolomics
DNA methylation
Transcriptomics (mRNA, miRNA)
Genome-wide association study (GWAS)

Child biological samples	---------- Child age (years) at sampling ----------
	At birth	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	>18
Whole blood																	X
Serum	X	X	X		X			X				X					X
Plasma
Buffy coat
Urine																	X
Hair
Teeth
Nails
Saliva												X
Purified DNA								X				X					X
Purified RNA
Red blood cells
Umbilical cord blood/tissue
Blood smear
Faeces/meconium
Exhaled breathe condensate
Sputum induction
Placenta

General information
	Pre-pregnancy	During pregnancy	<1	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18
Education
Income
Employment status
Job title
Single parenthood
Home address
Work address

Maternal characteristics related to the index pregnancy/child
Age at birth	X
Ethnicity
Country of birth
Planned pregnancy
Time to pregnancy
Fertility treatment
Prior spontaneous abortion (<22w)
Prior births	X
Ultrasound measurements
Doppler measurements
Preeclampsia
Gestational diabetes
Gestational hypertension
Gestational duration	X
Mode of delivery	X
Prenatal diagnostics
Medical termination of pregnancy

Maternal Exposures	---------- Timing of assessment ----------
	Pre-pregnancy	First trimester	Second trimester	Third trimester	Post pregnancy
Diet
Dietary supplements
Active smoking
Passive smoking
Alcohol consumption
Physical activity
Substance use
Medicine intake
Coffee drinking
Psychological distress (e.g. life-events, health behaviors, perceived stress)
Occupational exposures
Heavy lifts
Work hours
Air pollution
Access to green spaces
Built environment
Noise
Radiation, electromagnetic fields
Water contamination
Binge drinking
Pets
Farm animal exposure
Biomarkers of exposure
Mercury
Lead
Cadmium
Arsenic
Other metals
Polychlorinated biphenyl esters
Dicloro difenil tricloroetano
Hexachlorobenzene
Brominated flame retardants
Perflouralkyl compounds
Bisphenol A
Other bisphenols
Parabens
Benzophenones
Triclosan
Phthalates
Cotinine

Maternal health	---------- Timing of assessment ----------
	Pre-pregnancy	First trimester	Second trimester	Third trimester	Post pregnancy
Anthropometry
Weight
Height
Waist circumference
Clinical examinations
Blood pressure
Carotida intima media thickness
Pulse wave velocity
DEXA scans
Bioimpedence
Mental and neurological development
Mental health
Cognitive function (e.g. intelligence quotient)
Respiratory health
Asthma
Allergy
Musculo‐skeletal disease
Back pain
Neck pain
Arthritis
Other health outcomes
Cancer
Diabetes
Cardio‐vascular disease
Family history of chronic disease
Infectious disease
Fever
Autoimmune disease
Urinary symptoms
Sexual problems
Sleep disturbance
Biomarkers of health
Nephrology (e.g. creatinine, albumin)
Thyroid hormones
Inflammatory markers (e.g. C-reactive protein cytokines)
Immunologic markers (e.g. immunoglobulines)
Cortisol
Vitamines and micronutrients
Gonadal axis hormones (e.g. testosterone, estradiol)
Metabolism (e.g. cholesterol, LDL, HDL, insulin, triglycerides)
Metabolomics
DNA methylation
Transcriptomics (mRNA, miRNA)
Genome-wide association study (GWAS)

Maternal biological samples	---------- Timing of sampling ----------
	Pre-pregnancy	First trimester	Second trimester	Third trimester	Post pregnancy
Breast milk
Whole blood
Serum
Plasma
Buffy coat
Urine
Hair
Nails
Saliva
Purified DNA
Purified RNA
Red blood cells
Faeces

General information
	Pre-pregnancy	During pregnancy	<1	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18
Education
Income
Employment status
Job title
Single parenthood
Home address
Work address

Paternal characteristics related to the index pregnancy/child
Fertility treatment
Age at child's birth
Ethnicity
Country of birth

Paternal exposures	---------- Timing of assessment ----------
	Pre-pregnancy	During pregnancy	Post pregnancy
Diet
Dietary supplements
Active smoking
Passive smoking
Alcohol consumption
Physical activity
Substance use
Medicine intake
Coffee drinking
Psychological distress (e.g. life-events, health behaviors, perceived stress)
Occupational exposures
Heavy lifts
Work hours
Air pollution
Access to green spaces
Built environment
Noise
Radiation, electromagnetic fields
Water contamination
Binge drinking
Pets
Farm animal exposure
Biomarkers of exposure
Mercury
Lead
Cadmium
Arsenic
Other metals
Polychlorinated biphenyl esters
Dicloro difenil tricloroetano
Hexachlorobenzene
Brominated flame retardants
Perflouralkyl compounds
Bisphenol A
Other bisphenols
Parabens
Benzophenones
Triclosan
Phthalates
Cotinine

Paternal health	---------- Timing of assessment ----------
	Pre-pregnancy	During pregnancy	Post pregnancy
Anthropometry
Weight
Height
Waist circumference
Clinical examinations
Blood pressure
Carotida intima media thickness
Pulse wave velocity
DEXA scans
Bio impedence
Mental and neurological development
Mental health
Cognitive function (e.g. intelligence quotient)
Respiratory health
Asthma
Allergy
Musculo‐skeletal disease
Back pain
Neck pain
Arthritis
Other health outcomes
Cancer
Diabetes
Cardio‐vascular disease
Family history of chronic disease
Infectious disease
Fever
Autoimmune disease
Urinary symptoms
Sexual problems
Sleep disturbance
Biomarkers of health
Nephrology (e.g. creatinine, albumin)
Thyroid hormones
Inflammatory markers (e.g. C-reactive protein cytokines)
Immunologic markers (e.g. immunoglobulines)
Cortisol
Vitamines and micronutrients
Gonadal axis hormones (e.g. testosterone, estradiol)
Metabolism (e.g. cholesterol, LDL, HDL, insulin, triglycerides)
Metabolomics
DNA methylation
Transcriptomics (mRNA, miRNA)
Genome-wide association study (GWAS)

Paternal biological samples	---------- Timing of sampling ----------
	Pre-pregnancy	During pregnancy	Post pregnancy
Semen
Whole blood
Serum
Plasma
Buffy coat
Urine
Hair
Nails
Saliva
Purified DNA
Purified RNA
Red blood cells
Faeces

Comments and ideas

Comments and ideas