Premature Birth Clinical Trial
Official title:
Is it Possible to Prolong the Duration of Exclusive Breastfeeding in Premature Infants? a Prospectivt Study
NCT number | NCT02952950 |
Other study ID # | H-16000621 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | August 2019 |
Verified date | February 2018 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this project three studies examined two possible explanations and one possible preventive
intervention to early cessation of exclusively breastfeeding in premature infants.
Study 1 The content of protein in the milk of mothers, who delivers prematurely, is about a
third higher than in the milk from the mother who delivers on time. The nutritional
composition changes over time and the content of protein decrease. Therefore the premature
infant is at risk of protein deficiency. While the infant is feeding by tube this decreasing
content of protein can made up by adding, while it is more difficult when the infant is
exclusively breastfeeding. The hypothesis is that reduced protein content in breast milk is
associated to a fewer number of days where the premature infant is exclusively breastfed.
Study 2 The premature infant is characterized with immature muscle with a low tension and
therefore, a low ability to eat its needs by breastfeeding the first period. The transfer of
milk from mother to child is an interaction between the mothers and her milk ejection reflex
that establish a positive pressure on the milk and the child that have to establish a vacuum.
The hypothesis is that the premature infants suction power is too weak to establish
sufficient intraoral vacuum to ensure milk transfer from the breast to the infant and it can
be related to a fewer number of days where the infant is exclusively breastfed.
Study 3 The premature infants low muscle tone and its immaturity also influence on the
organization and the quality of movements, marked as neuro motor processes. These processes
form the oral motor base supporting movement which involves the infant ability to establish
vacuum. The hypothesis is that Oral Stimulation for a specific program in 5 minutes before
the minimum 2 meals per. day for at least 14 days increases the preterm infant's ability to
create intra oral vacuum and thus the power to transfer milk from the breast, thereby
extending the number of days when the infant is exclusively breastfed.
200 infants are included consecutively, as a recurring cohort in all 3 studies. In Study 1
the mothers' milk is analyzed in order to the content of protein. In Study 2 the infant
suction is assessed by vacuum measurement. In study 3 the families are randomized to an
intervention or control group and parents off 100 infants are guided by occupational
therapists in a program of oral stimulation of their child.
Status | Completed |
Enrollment | 211 |
Est. completion date | August 2019 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 37 Weeks |
Eligibility |
Inclusion Criteria: - mothers: with premature infant i.e. the infant's gestational age is equal to or maximum of 36 + 6 - intend to breastfeed. - The mother or father / other primary caregiver understand Danish, Norwegian, Swedish or English. Exclusion Criteria: - mothers: will not / can´t breastfeed because of illness or abuse such as: HIV and drugs. - In addition, if the infant has a disability which makes it difficult to breastfeeding or if the infant is physiologically unstable, for example due to reduced lung function. |
Country | Name | City | State |
---|---|---|---|
Denmark | Paediatric Department section Neonatology | Hvidovre | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of Breastfeeding | Exclusively breastfeeding duration measured in number of whole days and defined as the infant is exclusively fed with breastmilk | 6 month | |
Secondary | Content of protein in breastmilk | Protein content are examined once a week as long the family is hospitalized and 6 weeks after the terminator date. | 6 weeks after the terminator date | |
Secondary | Intra Oral Vacuum | Intra oral vacuum are examined once a week as long the family is hospitalized and 6 weeks after the terminator date. | 6 weeks after the terminator date |
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