Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions (MiLC)
Milk in Life Conditions (MiLC): Characterizing the Bacterial Composition of Human Milk Pumped and Stored in "Real-life" Conditions
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participants will donate 1 oz of human milk during each of two consecutive pumping sessions, for a total volume of 2 oz donated on one day. To collect this human milk, participants will be asked to fully express one breast during each pumping session. Participants will pump once with the participant's own pump set-up and once with the sterile pump set-up (provided by the research team). Women will be randomized to which pump is used first.
Randomization will be done using stratified randomization as follows: participants were stratified by how their infants were fed, namely whether infants were fed human milk only vs. human milk and complementary foods). Then, randomization was conducted within each strata. The researchers aim to have a minimum of 25 participants in each stratum.
All human milk collections will occur at participants' homes between 0700 and 1100 hours. The second pumping session must begin 3 hours (+/-30 minutes) after the beginning of the first pumping session (e.g. the first pumping session at 7:30 am and the second at 10:30 am). Participants will elect from which breast to donate human milk and that breast will be used for both pumping sessions. Participants will be asked not to nurse from or pump that breast during the 2 hours before the first pumping session and not until after the second pumping session (a total of ~5.5 hours).
From the milk produced during each pumping session (which could be up to ~6 oz), researchers will collect 1 oz using a sterile, plastic syringe. Participants will keep the remaining volume of milk. Each ounce of milk collected will be separated into 5 sterile containers (provided). Participants will store donated milk at home until it is picked up by a researcher 2, 4, and 30 days after pumping.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New York
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Ithaca, New York, États-Unis, 14853
- Hay Laboratory, B75C Wing Hall, Cornell University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Lactating women over the age of 18 years
- Self-reported as healthy women and infants
- Use an electric breast pump
- Confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions where pumping sessions are 3 hours (+/- 30 minutes) apart and between 0700-1100 hours.
- Able to store donated milk at home for 30 days
- Have infants who do not consume formula or only consume formula episodically as long as the most recent formula-feeding occurred > 2 weeks before the day milk is pumped for this study.
Exclusion Criteria:
- Not confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions, 3 hours (+/- 30 minutes) apart and between the hours of 0700-1100 hours.
- Infant consumption of formula in the past 2 weeks
- Current indication of breast infection (e.g., breast pain, discomfort, lumps, mastitis with fever, red streaks, or hard red portions of the breast)
- Breast pain that the woman does not consider "normal" for lactation/breastfeeding
- Signs/symptoms of acute illness in woman or infant in past 7 days including fever (rectal or temporal temperature ≥99.5 F), dark green nasal discharge, diarrhea (abrupt onset of 3 or more excessively "loose" stools in one day), vomiting (where infant vomiting is not associated with feeding), or severe cough.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Sterile pump set-up first
Participants will pump with sterile pump set-ups first.
Approximately 3 hours later, participants will pump with their own pump set-ups.
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Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).
Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).
|
|
Expérimental: Mother's Own pump set-up first
Participants will pump with their own pump set-ups first.
Approximately 3 hours later, participants will pump with sterile pump set-ups.
|
Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).
Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Bacterial Community Richness
Délai: 0 days after pumping
|
Richness is the total number of different bacterial taxa detected in the sample.
This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.
|
0 days after pumping
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Bacterial Community Diversity
Délai: 0 days after pumping
|
Bacterial community diversity will be assessed using the the Shannon diversity index.
The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species.
If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i).
This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.
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0 days after pumping
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Total Live Aerobic Bacterial Counts
Délai: 0 days after pumping
|
Number of live total aerobic bacteria in milk assessed by aerobic culturing of milk on plate count agar.
Reported as colony-forming units (CFU)/mL.
|
0 days after pumping
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kathleen M. Rasmussen, ScD, Cornell University
- Chercheur principal: Anthony Hay, PhD, Cornell University
- Directeur d'études: Sarah Reyes, MS, Cornell University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB #: 1608006566
- 2T32DK007158-42 (Subvention/contrat des NIH des États-Unis)
- NYC-399436 (Autre subvention/numéro de financement: NIFA/USDA)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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