Infants Admitted to Neonatal Units Clinical Trial
Official title:
Which Infants in a Neonatal Unit Are at Most Risk of Feeding Difficulties?
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.
| Status | Recruiting |
| Enrollment | 506 |
| Est. completion date | |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 12 Months |
| Eligibility |
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. |
Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Lancashire Teaching Hospitals | Preston | Lancashire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Central Lancashire |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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'. | 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. | 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. | No |
| Secondary | Slow attainment of full oral feeding (preterms only). Measured as 'Yes - oral feeding not achieved at 37 weeks', 'No', or 'Information not available'. | 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. | Data will be collected retrospectively. Slow attainment of oral feeding will be determined by feeding method at 37 weeks gestational age. | No |