Multi-component Package for Skin Health and Allergen Exposure Strategy to Prevent Food Allergy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
The goal of this clinical trial is to determine if a multi-component environmental package (MEP) can prevent food allergies among infants at risk of developing food allergies in early life.
Researchers will compare the multi-component environmental package to regular care to see if the MEP works to prevent food allergies. Participants will:
- Be assigned to the multi-component environmental package or regular care once their baby is born
- Complete a weekly diary
- Attend in-office visits at 4 and 12 months of age
- Complete web-based questionnaires at 4, 6, 9 and 12 months of age
详细描述
Strategies that promote a healthy and diverse microbiome from early life, including careful management of hygiene practices, may be effective in preventing allergies. Excessive bathing, in frequency or intensity, using soaps and similar chemicals, may disrupt the skin barrier and developing microbiome, promoting aberrant immune responses directly or via promoting colonization by pro-allergic microbes.
Strategies to reduce antimicrobial use, detergent/soap exposure, scheduled bathing frequency, skin allergen exposure, and promoting microbiome diversity may support immune tolerance and prevent the development of food allergy. Our systematic reviews show that no clinical trial currently addresses the effect of an environmental package for the prevention of food allergy. Thus, investigators propose SHAPE, the first trial evaluating the feasibility of a multicomponent environmental package (MEP) as an approach to prevent food allergy in early life.
This randomized, assessor blinded, parallel, single center pilot trial will assess the feasibility in implementing MEP in preventing food allergy among infants. Birthing parents will be consented as early as 32 weeks gestational age up until delivery. After delivery, study staff will confirm eligibility and randomization will occur within 24 hours of birth among eligible neonates receiving either MEP (intervention) or standard of care (control) group in a 1:1 ratio.
The Evidence in Allergy group at McMaster University will coordinate this pilot study. Clinicians at prenatal clinics or postpartum ward of McMaster University Medical Centre (MUMC) in Hamilton, Ontario, Canada will identify and invite pregnant women during third trimester to enroll their babies after birth in the study. Once the baby is born, study staff will screen and assess eligibility criteria for randomization. This trial will enroll healthy singleton, neonates born at term without complications. To be eligible, the newborn will have at least one of the following risk factors: is an only child (no live siblings); first-degree relatives (parents and/or siblings) with history of food allergy, allergic rhinitis/conjunctivitis, asthma, or atopic dermatitis.
Once the signed consent form and eligibility are confirmed, study staff will randomize the participants to either the MEP (intervention group) or the standard of care (control group) within 24 hours of birth. Study staff will provide face-to-face instructions to the parents of the enrolled infant according to the assigned group. After enrollment, study staff will schedule follow-up calls and visits to collect data on adherence through web-based questionnaires at 4, 6, 9 and 12 months of age and in-office visits at 4 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinicians involved in the participants routine care will be blinded to which arm they are assigned to. To blind assessors, the study team will remind patients to not reveal information as to which group they are assigned. Blinded study staff (e.g. trial analyst, statistician, data manager) will remain blind to the allocated intervention until database lock.
入排标准
- 年龄范围
- 37 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy singleton, neonates born at term (gestational age ≥37 weeks) (e.g. newborn without complications such as severe respiratory conditions, major congenital abnormalities, severe inborn errors of immunity [e.g. severe combined immunodeficiency], severe neonatal infections, neurologic impairment, and major gastrointestinal disorders).
- •The newborn has any or at least one of the following risk factors: is an only child (no live siblings); first-degree relatives (parents and/or siblings) with history of food allergy, allergic rhinitis/conjunctivitis, asthma, or atopic dermatitis.
- •Parent(s)/guardian provided informed consent for the child's study participation.
排除标准
- •Newborns born to mothers with positive routine prenatal screening for any of the vertically transmitted diseases (e.g. hepatitis B, hepatitis C, active syphilis or genital herpes simplex, Chlamydia trachomatis, gonorrhea and human immunodeficiency virus [HIV]) that may prevent adherence to any of the recommendations of the environmental packages.
- •Inability to adhere to the study procedures, e.g. severe maternal conditions (e.g. eclampsia, life-threatening conditions requiring intensive care admission) or neonatal skin conditions that require specific care practices.
- •Ongoing participation in another interventional study (e.g. trials involving skin care with topical creams, medication or interventions related to allergy prevention) that may interfere with the current study.
- •No access to phone, internet, or email (requirements to contact participant/guardian).
- •Planning to move out of the province within 12 months of study enrollment.
研究组 & 干预措施
Intervention Group
Description of the recommendations included in the intervention package
- Delay first bath until target of 7 days after birth and use only water for the first bath (i.e. no soap or cleanser).
- Bathe a target of once per week.
- Avoid bubble baths, harsh soaps and detergents (e.g. surfactants- or lye-containing agents detailed below).
- Avoid using antimicrobial (disinfectant) wipes (e.g. "wet wipes" such as Dr. Brown's, Parent's choice, Aleva Naturals, Munchkin Arm & Hammer, Chicco cleaning wipes) for cleaning skin outside of the perineum/anus.
- Avoid using dishwasher with detergents or rinse-aids for washing baby feeding devices, soothers, and toys (e.g. breast pump, nursing bottles, nipples, pacifiers, teething devices, or toys).
- Avoid exposing the skin to food, e.g. eating over top of baby, or handling baby with food residue on hands (e.g. peanut butter), or kissing baby with food residue on lips or in mouth.
干预措施: Multi-component environmental package (Other)
Control Group
If assigned to the control group, the parents will be advised to continue their preferred routine practices.
干预措施: standard of care (Other)
结局指标
主要结局
Adherence
时间窗: Web-based questionnaires at 4, 6, 9 and 12 months will track adherence.
Investigators will measure the proportion of participants adhering to the protocol (MEP or control). Parents will log weekly details about bathing frequency, use of soap or detergents for bathing or using detergents for cleaning baby essentials and environmental exposure of food allergen to skin in weekly electronic diary card using REDCap. Reasons for non-adherence will be recorded for both groups. Successful adherence is anticipated if at least 50% of the participants completes the adherence form at the four study (4, 6, 9 and 12 months of age) time points and completes weekly diary card (at least 38 out of 52 weeks of follow-up).
Recruitment
时间窗: 12- months from study initiation
Investigators will determine the number of participants randomized to study groups (Group 1 or 2) over one year from the date of first accrual. A screening log will track eligible newborns and be used to assess the recruitment rate every week.
Retention
时间窗: Web-based questionnaire at 4, 6, 9, and 12 month age follow-up
Study staff will track the proportion of participants completing all scheduled follow-ups and providing complete data. Reasons for incomplete data will be recorded for both groups (e.g., admission to hospital due to any illness) from process-related reasons (i.e., insufficient reminders, too difficult to implement, other reasons specified by parents).
次要结局
- Data collection on number of adverse events (AE) related to allergic reactions, skin and gastrointestinal conditions(Until 12 months of age (end of study))