Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children Over Time (IMPACT)
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ClinicalTrials.gov Identifier: NCT04017520 |
Recruitment Status :
Active, not recruiting
First Posted : July 12, 2019
Last Update Posted : January 12, 2024
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Condition or disease |
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Atopy Atopic Dermatitis Eczema Wheezing Food Allergy in Infants |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 221 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 5 Years |
Official Title: | Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children and Toddlers |
Actual Study Start Date : | January 18, 2018 |
Actual Primary Completion Date : | October 30, 2021 |
Estimated Study Completion Date : | October 30, 2025 |
Group/Cohort |
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Mother-infant dyads
221 mother-infant dyads enrolled at delivery and followed longitudinally at regularly scheduled well child checks (4, 16, 24, and 48- weeks) at a primary care outpatient pediatric clinic affiliated with an academic medical center. Eligible mothers will be those who plan to breast feed for 16 weeks and infants born at term (37-42 weeks). The cohort will be divided post-hoc into atopic and non-atopic groups based on the primary outcome measure (described below). No intervention will be administered. |
- Atopy [ Time Frame: 0-48 weeks after delivery ]Infant development of one or more of the following atopic conditions at any point during the first 12 months (48 weeks) after birth: atopic dermatitis, reactive airway (wheezing), or food allergy. When possible specific allergy will be confirmed with IgE serum testing at 48 weeks.
- Food Allergy [ Time Frame: 0-48 weeks after delivery ]Food allergy: defined by affirmative parent response to "Has your baby ever had problems caused by food, such as an allergic reaction, sensitivity, or intolerance?" on the Infant Feeding Practices (IFP) Survey, administered at 4, 16, 24, and 48 weeks. Confirmed by serum RAST testing at 48 weeks.
- Reactive Airway [ Time Frame: 0-48 weeks after delivery ]Defined by an affirmative parent response to "Has your baby had wheezing in the chest or bronchitis or whistling during his/her first 12 months of life?" on the International Study of Wheezing in Infants (EISL-WQ) Survey, administered at 48 weeks. Confirmed by serum RAST testing with the Northeast Allergen Panel at 48 weeks. Applied to Pediatric Asthma Risk Score criteria.
- Atopic Dermatitis [ Time Frame: 0-48 weeks after delivery ]Defined by ICD-10 diagnosis and quantified by SCORing Atopic Dermatitis (SCORAD) Survey at 4, 16, 24, or 48 weeks (<25: mild, 25-50: moderate, >50: severe).
- Cumulative infant exposure to breast milk micro-transcriptome components [ Time Frame: 0-23 weeks after delivery ]
For each infant, exposure to individual small non-coding RNAs that are robustly expressed (counts > 10 in >90% of samples with RNA sequencing depth of 5 million reads) in maternal breast milk (MBM) will be calculated as follows (example for hsa-miR-26a):
- Exposure in weeks 0-3: Volume of MBM/day x [miR-26a] (ppm) x 28 days (or until breastfeeding ceased) x Proportion of feeds consisting of MBM plus...
- Exposure in weeks 4-15: Volume of MBM/day x [miR-26a] (ppm) x 84 days (or until breastfeeding ceased) x Proportion of feeds consisting of MBM plus...
- Exposure in weeks 16-23: Volume of MBM/day x [miR-26a] (ppm) x 56 days (or until breastfeeding ceased) x Proportion of feeds consisting of MBM = Total miR-26a exposure (ppm) in the first 6 months
- Allergen Exposures [ Time Frame: 4-weeks after delivery ]Documented for mother-infant dyads at 4-weeks post delivery using the National Survey of Lead hazards and Allergens in Housing (NSLAH) Survey, developed by the Department of Housing and Urban Development in coordination with the National Institute of Environmental Health. The survey asks about the age of housing, number of occupants, heating source, and the presence/absence of air conditioning, air filtration system, mold/mildew, dehumidifier, pets, cockroaches, mice/rats, and cigarette smokers in the home.
- Maternal Diet [ Time Frame: 0, 4, and 16-weeks after delivery ]Documented at 0, 4, and 16 weeks using a modified version of the Diet History Questionnaire (DHQ), developed by the National Cancer Institute. Briefly, the survey measures servings of: hot/cold cereals, milk, soda, fruit juice, coffee/tea, sweetened fruit/sports drinks, fruit, green leafy vegetables, fried potatoes, other potatoes, beans, rice, salsa, pizza, tomatoes, cheese, red meat, processed meat, bread, chocolate, doughnuts/muffins, baked goods, ice cream, and pop-corn. Responses are recorded as: never, once per month, 2-3 times per month, once per week, 2 times per week, 3-4 times per week, once per day, 2-3 times per day, and 3-4 times or more per day.
- Infant Sleep [ Time Frame: 4, 16, 24, and 48-weeks after delivery ]The Brief Infant Sleep Questionnaire (BISQ) will be administered at 4, 16, 24, and 48-weeks. Nine qualitative questions about infant sleep practices are recorded, including: sleeping arrangement, sleep position, time spent during sleep (in hours), time spent in daytime sleep (in hours), average number of night time awakenings, amount of night-time wakefulness, sleep onset latency, mode of sleep initiation, time of sleep initiation. Affirmative parental response to, "Do you consider your child's sleep to be a problem?" will be used to dichotomize those with atypical sleep habits.
- Infant Fussiness [ Time Frame: 4-weeks after delivery ]A modified version of the Infant Colic Scale (ICS) will be administered at 4-weeks. This modified scale assesses 12 items on a six point Likert scale (strongly disagree, disagree, slightly disagree, slightly agree, agree, strongly agree). A higher score portends greater likelihood of colic, with average score across the 12 items of >2.9 being consistent with colic. Questions generally assess gastrointestinal symptoms, infant temperament, and parent-infant interaction.
- Infant Growth [ Time Frame: 0, 4, 16, 24, 48-weeks; 2, 3, 4, and 5 years after delivery ]Weight for length z-score will be recorded from the electronic medical record at 0, 4, 16, 24, and 48 weeks, as well as 2, 3, 4, and 5 years after delivery. The change in weight for length z-score from 0-48 weeks will be the primary outcome, where a positive z-score change will indicate relative weight increase, and a negative z-score change will indicate relative weight decrease.
- Infant Development [ Time Frame: 9, 18, and 30-months after delivery ]Survey of Wellbeing in Young Children (SWYC) scores will be abstracted from the electronic medical record at 9, 18, and 30-months. Children with a total score <12 (at 9-months of age), <9 (at 18-months of age), or <11 (at 30-months of age) will be defined as those with potential developmental delays.
- Long-term Child Atopy [ Time Frame: 2, 3, 4, and 5 years after birth ]
Child development of one or more of the following atopic conditions at any point during the first 5 years after birth:
- Atopic dermatitis
- Wheezing
- Food allergy
- Allergic rhinitis
- Allergic conjunctivitis
- Asthma
All defined by clinical documentation in the child's medical problem within the electronic medical record.
- Infant stool micro-transcriptome [ Time Frame: 0-weeks and 48-weeks after delivery ]Small non-coding RNAs (including bacterial RNAs) will be quantified in stool from each infant at 0-weeks and 48-weeks using high throughput RNA sequencing.
- Infant saliva micro-transcriptome [ Time Frame: 0, 4, 16, 24, and 48-weeks after delivery ]Small non-coding RNAs (including bacterial RNAs) will be quantified in saliva from each infant at 0, 4, 16, 24, and 48-weeks using high throughput RNA sequencing.
- Infant cytokines [ Time Frame: 24-weeks after delivery ]TH1 and TH2 cytokines, including CCL5, IFN-gamma, IL-1, IL-4, IL-5, IL-6, IL-8, IL-10, IL-13, eotaxin, TNF-alpha, TGF-beta-1, and TGF-beta-2 will be measured in infant saliva using a luminex assay.
- Maternal breast milk cytokines [ Time Frame: 4-weeks, 16-weeks, 24-weeks ]T-helper (TH-)1 and TH-2 cytokines, including C-C Motif Chemokine Ligand (CCL)-5, interferon (IFN)-gamma, interleukin (IL)-1, IL-4, IL-5, IL-6, IL-8, IL-10, IL-13, eotaxin, tumor necrosis factor (TNF)-alpha, transforming growth factor (TGF)-beta-1, and TGF-beta-2 will be measured in maternal breast milk using a luminex assay. Serotonin and melatonin will also be interrogated.
- Infant genetics [ Time Frame: 48-weeks after delivery ]Deoxy-ribonucleic acid will be extracted from infant saliva for interrogation of single nucleotide polymorphisms and copy number variants related to atopy risk.
- Maternal genetics [ Time Frame: 0-weeks after delivery ]Deoxy-ribonucleic acid will be extracted from maternal saliva for interrogation of single nucleotide polymorphisms and copy number variants related to atopy risk.
- Infant IgE [ Time Frame: 48-weeks after delivery ]Specific IgEs will be measured in the serum of all infants who meet atopy criteria at 48-weeks, including 1) aeroallergens (bermuda grass, timothy grass, cockroach, penicillium notatum, cladosporium herbarum, aspergillus fumigatus, mucor racemosus, alternaria tenuis, box elder maple, common silver birch, oak, elm, walnut tree, maple leaf sycamore, cottonwood poplar, white ash, mulberry, red cedar, ragweed, mugwort, pigweed, sheep sorrel, cat dander, dog dander, mouse); 2) food allergens (cow's milk, wheat, almond, shrimp, egg yolk, egg white, codfish, sesame seed, soybean, hazelnut, tuna, salmon, scallop, pecan, cashew, walnut, and peanut); and 3) total IgE.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 0 Days to 7 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Mothers between the ages of 18 years adn 35 years
- Mothers plan to breast feed for minimum of 16 weeks (cessation of breastfeeding prior to this timepoint will not result in exclusion)
- Infants delivered at term (37 - 42 weeks)
Exclusion Criteria:
- Maternal morbidities that could affect ability to breastfeed or influence the breast milk micro-transcriptome (eg. cancer, drug addiction, HIV).
- Plan for infant adoption, or family move >150 km from the medical center within 12 months of delivery
- Presence of congenital anomaly or neonatal condition that significantly affects a newborn's ability to feed (e.g. cleft lip/palate, metabolic disease, or prolonged neonatal intensive care unit (NICU) admission >7 days)
- Plan to seek primary pediatric care outside the academic medical center
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017520
United States, Pennsylvania | |
Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Steven Hicks, MD/PhD | Milton S. Hershey Medical Center |
Responsible Party: | Steven Hicks, Assistant Professor of Pediatrics, Milton S. Hershey Medical Center |
ClinicalTrials.gov Identifier: | NCT04017520 |
Other Study ID Numbers: |
STUDY00008657 5295 ( Other Grant/Funding Number: Gerber Foundation ) |
First Posted: | July 12, 2019 Key Record Dates |
Last Update Posted: | January 12, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is a plan to share high throughput RNA sequencing data as de-identified fastq files linked with basic medical and demographic data through the Short Read Archive. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Atopy Wheezing Eczema Allergy Food allergies |
Dermatitis Eczema Hypersensitivity Food Hypersensitivity Respiratory Sounds |
Skin Diseases Skin Diseases, Eczematous Hypersensitivity, Immediate Immune System Diseases Signs and Symptoms, Respiratory |