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Which Infants in a Neonatal Unit Are at Most Risk of Feeding Difficulties?

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ClinicalTrials.gov Identifier: NCT02867410
Recruitment Status : Unknown
Verified November 2016 by Sarah Edney, University of Central Lancashire.
Recruitment status was:  Recruiting
First Posted : August 16, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Sarah Edney, University of Central Lancashire

Brief Summary:

Feeding problems are common among babies who are born preterm or who have medical conditions. It is not yet known which babies admitted to neonatal units are most at risk of feeding problems. Studies have shown that the degree of prematurity and the presence of additional health problems make feeding difficulties more likely. However, research does not always agree on which health problems are most associated with feeding problems and many studies on prematurity exclude babies with the most complex health problems. Additionally, not all babies with complex health problems and feeding problems are premature. This study aims to answer the question 'Is gestational age or medical status the better indicator of risk for feeding difficulties?'

This research will study babies admitted to the Royal Preston Hospital Neonatal Unit in 2015 using routinely collected data about stored on BadgerNet, a patient data management system. Coded data will be collected for the following variables: gestational age category (extremely preterm, very preterm, moderate-late preterm, term), medical status by number and type of bodily systems with health issues, and feeding outcome (full oral feeding by 37 weeks, 40 weeks, before discharge, or discharged home with tube feeding).

Appropriate statistical tests will be used to determine the presence or absence of correlation between gestation age and medical variables and feeding outcome. Information from this study will be used to inform neonatal service delivery (including Speech and Language Therapy referral criteria and caseload prioritization) and areas in need of further research.


Condition or disease Intervention/treatment
Infants Admitted to Neonatal Units Other: No intervention

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 506 participants
Time Perspective: Retrospective
Official Title: Which Infants in a Neonatal Unit Are at Most Risk of Feeding Difficulties?
Study Start Date : November 2016
Estimated Primary Completion Date : December 2016



Primary Outcome Measures :
  1. Presence or absence of a feeding difficulty. Measured as 'Yes - achieved oral feeding after 40 weeks but before discharge', 'Yes - discharged home tube feeding', 'No', or 'Information not available'. [ Time Frame: Data will be collected retrospectively. Presence or absence of a feeding difficulty will be determined by feeding method at 40 weeks gestational age. For infants who are not fully orally fed at 40 weeks, this measure will be taken again at discharge. ]
    Data will be collected retrospectively for all infants admitted during 2015. Presence or absence of a feeding difficulty will be determined by the documented feeding method at 40 weeks gestational age. Presence of a feeding difficulty is defined as partial or full non-oral nutrition at 40 weeks gestational age. Absence of a feeding difficulty is defined as full oral feeding (taking all feeds from breast, bottle or cup with no tube feeding) by 40 weeks gestational age. Where information is not available, the infant will be excluded from analysis. The percentage of infants in the 'Yes' and either of the 'No' categories will be determined for each of the 'gestational age' categories, for each of the 'medical status - number of systems involved' categories, and each of the 'medical status - types and combinations' categories. Statistical analysis will be performed to determine whether gestational age or medical status is the better predictor of feeding difficulty.


Secondary Outcome Measures :
  1. Slow attainment of full oral feeding (preterms only). Measured as 'Yes - oral feeding not achieved at 37 weeks', 'No', or 'Information not available'. [ Time Frame: Data will be collected retrospectively. Slow attainment of oral feeding will be determined by feeding method at 37 weeks gestational age. ]
    Data will be collected retrospectively for all preterm infants admitted during 2015. Presence or absence of slow attainment of oral feeding will be determined by the documented feeding method at 37 weeks gestational age. Slow attainment of oral feeding is defined as partial or full non-oral nutrition at 37 weeks gestational age. The percentage of infants in the 'Yes' and 'No' categories will be determined for each of the preterm 'gestational age' categories, for each of the 'medical status - number of systems involved' categories, and each of the 'medical status - types and combinations' categories. Statistical analysis will be performed to determine whether gestational age or medical status is the better predictor of slow attainment of oral feeding.



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants admitted to a Level 3 Neonatal Unit
Criteria

Inclusion Criteria:

• Admitted to the Royal Preston Hospital Neonatal Unit at any point during 2015

Exclusion Criteria:

• All required data regarding their gestational age, medical status, and feeding outcome is not available.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867410


Contacts
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Contact: Sarah K Edney +44 07738337413 sarah.k.edney@gmail.com

Locations
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United Kingdom
Lancashire Teaching Hospitals Recruiting
Preston, Lancashire, United Kingdom, PR2 9HT
Contact: Sarah K Edney       sarah.k.edney@gmail.com   
Sponsors and Collaborators
University of Central Lancashire

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Responsible Party: Sarah Edney, Staff Contractor - Research Internship, University of Central Lancashire
ClinicalTrials.gov Identifier: NCT02867410     History of Changes
Other Study ID Numbers: IRAS Project ID: 203827
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No