- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03938675
Early Use of Raw Milk and Breastfeeding Continuation (DOAL)
Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study
BACKGROUND:
Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units.
OBJECTIVES:
This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation.
METHODS:
This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Eligible neonates were those admitted between April 2012 and June 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.
Exclusion Criteria:
- Neonates with parents not fluent in French were excluded.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Raw maternal own milk before day 7
Without any intervention, investigators observed whether neonates received raw MOM during the first week of life.
Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7.
|
No Raw maternal own milk before day 7
Without any intervention, investigators observed whether neonates received raw MOM during the first week of life.
Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in breastfeeding after hospital discharge
Tidsram: On Day 60 and Day 180 after hospital discharge
|
Breastfeeding was defined as the consumption of any mother's own milk (MOM), provided either directly at the breast or after having been expressed.
Information on breastfeeding continuation was extracted from the electronic chart during the last 2 days preceding hospital discharge.
It was classed as "exclusive" when all the fed milk was MOM, or "partial" when it was completed by other milk and/or food.
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On Day 60 and Day 180 after hospital discharge
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sophie Laborie, MD, Hospices Civils De Lyon
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Andra studie-ID-nummer
- DOAL
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