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

NCT02867410 | Unknown

• 1 other identifier: IRAS Project ID: 203827
• Study Type: observational
• Target: 506
• Locations: 1 country
• Sites: 1

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.

Conditions

Infants Admitted to Neonatal Units

Outcome Measures

Primary Outcomes (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'.

  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.

Secondary Outcomes (1)

• 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. Slow attainment of oral feeding will be determined by feeding method at 37 weeks gestational age.

Interventions

No intervention OTHER

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants admitted to a Level 3 Neonatal Unit

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Central Lancashire: lead

Study Sites (1)

Lancashire Teaching Hospitals

Preston, Lancashire, PR2 9HT, United Kingdom

RECRUITING

Central Study Contacts

Sarah K Edney

CONTACT

+44 07738337413; sarah.k.edney@gmail.com

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Contractor - Research Internship

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 16, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)