Human milk contains (a combination of) components that might protect infants from (respiratory tract) infections and allergic diseases.
ID
Bron
Verkorte titel
Aandoening
(respiratory) infections and allergic diseases.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Parent-reported medically attended respiratory tract infection during the first year of life
Achtergrond van het onderzoek
Background of the study:
We aim to identify mechanisms by which breast feeding prevents respiratory tract infections. A healthy birth cohort (n=1000) will be set-up and studied during the first year of life. Human milk will be collected repeatedly and analysed to provide insights into the protective capacity of human milk components against (respiratory tract) infections and allergies. A subgroup will be further analyzed to obtain insight in transfer of maternal immunity to the child. By collecting additional cord blood, amniotic fluid and maternal blood samples, we will analyze the transfer of maternal immunity.
Objective of the study:
Primary objective: 1. To identify the components in human milk (e.g. nutrients, oligosaccharides, fatty acids and (pathogen specific) immunoglobulins) that have a protective effect against respiratory tract infections during the first year of life. Secondary objective: 2. The underlying mechanism of the components in human milk that offer protection from respiratory tract infections during the first year of life. 3. To identify the components in human milk (e.g. nutrients, oligosaccharides, fatty acids and (pathogen specific) immunoglobulins) that have offer from developing allergies during the first year of life and to identify the underlying mechanism of these components. 4. To study the alterations in human milk composition at various time points. 5. To gain insight in the transfer of maternal immunity to their child via human milk, amniotic fluid and the placenta.
Study design:
The study is designed as a prospective observational cohort study, including 1000 healthy mother-child pairs. Directly after birth we will collect data from all children enrolled through a questionnaire that is send to parents every 2 weeks. The questionnaires will be used to collect data about episodes of (respiratory tract) infections and already developed allergies during the first year of age. Meanwhile, we will collect human milk samples at four time points: within 1 week postpartum and after 1 month, 3 months and 6 months postpartum. By collecting human milk at these time points, we expect to collect samples from all relevant time-dependent types of human milk. The human milk samples will be stored until analysis at the biobank facility of the UMC Utrecht. After analysis of human milk composition is performed and clinical data collected, we will compare the two database in order to find beneficial profiles of human milk components. Additionally we will also collect additional samples to research what the influence of breastfeeding is on immune development compared to other routes that are enrolled in the transfer of maternal immunity to the neonate. This we will de in a subgroup of 20 mother-child dyads. The samples that we will collect are cord blood samples, a maternal blood sample and an amniotic fluid sample. Jacobino et al. showed that antibodies retrieved form human amniotic fluid protected mice pups against RSV-infections (JACOBINO2016). Very little is known about the protective value antibody titers in cord blood. Active placental transport of maternal antibodies to the neonatal blood has been described, but little is known about the effectiveness of these antibodies (KOHLER1966). To obtain more insight in the effect of the antibodies that are being transferred by breastfeeding, we will compare the effect of breastfeeding to the antibodies in cord blood and amniotic fluid. We will also collected saliva samples in the children enrolled n this subgroup at 1 week, 1, 3, 6, and 12 months postpartum. Saliva samples will be used to study immune development in children.
Doel van het onderzoek
Human milk contains (a combination of) components that might protect infants from (respiratory tract) infections and allergic diseases.
Onderzoeksopzet
Inclusion at the first week postpartum, human milk sample collection at 1 week and 1, 3 and 6 months postpartum. Two-weekly questionnaires send to participants until children reach the age of one.
Onderzoeksproduct en/of interventie
None.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- All mother-child dyads that live in a proximity to Utrecht (because of logistical issues) and/or gave birth at the WKZ.
- Parents should have the intention to continue breastfeeding until at least 3 months postpartum
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Concerning the child:
(inborn) severe cardiac or pulmonary disorders or other severe organ diseases
- Extreme prematurity (defined as GA<32 weeks).
- Concerning parents:
- Acquired or innate immune deficiencies (excluding asthma, eczema and allergies).
- The (lactating) mother receives medication or has a physical condition which forms a contraindication for breastfeeding.
- Insufficient control of the Dutch language (i.e. at least B1 level).
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9056 |
CCMO | NL74946.041.20 |
OMON | NL-OMON51989 |