Infants Admitted to Neonatal UnitsNCT02867410
Which Infants in a Neonatal Unit Are at Most Risk of Feeding Difficulties?
An observational study of Infants Admitted to Neonatal Units, run by University of Central Lancashire at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Infants Admitted to Neonatal Units
- How many people
- 506 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants admitted to a Level 3 Neonatal Unit
Who may be able to join
- Admitted to the Royal Preston Hospital Neonatal Unit at any point during 2015
Who cannot join
- All required data regarding their gestational age, medical status, and feeding outcome is not available.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Lancashire Teaching Hospitals
Preston, Lancashire, PR2 9HT
Sarah K Edney, sarah.k.edney@gmail.com
About this study
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.
Read the detailed description
It is known that the incidence of feeding problems is high in neonatal populations and certain patient groups appear to be particularly at risk. It is not yet known which infant groups admitted to Level 3 Neonatal Units are at most risk of feeding problems and in need of specialist feeding assessment and interventions. While many studies have examined the impact of prematurity and additional medical problems on feeding outcomes, most studies to date are limited to sub-populations, and/or do not investigate how best to identify the babies who are at most risk of feeding difficulties. Neonatal Speech and Language Therapists require information about feeding risks and outcomes for the neonatal population as a whole for caseload prioritization and to target populations most in need of specialist feeding interventions.
Babies born extremely preterm (before 28 weeks gestational age) and very low birth weight (less than 1500 grams at birth) have been identified as slower to achieve full oral feeding than those born at an older gestational age and higher birth weight. Certain medical problems have been found to correlate with feeding outcomes in preterms. Impaired respiratory function, gastrointestinal complications, neurological involvement, and heart defects have all been associated with delayed feeding progression and poor feeding outcomes.
This study aims to determine if gestational age at birth or number and type of medical conditions is the better indicator of risk of feeding disorders in infants admitted to a Level 3 neonatal unit.
Design:
Prognostic study using retrospective case note analysis.
Setting:
A Level 3 Neonatal Unit (including intensive care, high dependency, and special care) at the Royal Preston Hospital.
Procedure:
A retrospective audit of routinely collected data will be undertaken and analysed. The BadgerNet patient record management system is updated daily for all babies in neonatal units around the country. Data will be collected from the BadgerNet daily notes and discharge summary and added to a bespoke spreadsheet prior to statistical analysis. Data collection will be conducted by a member of the Royal Preston Hospital Neonatal Unit clinical team. No patient identifiable data will be collected. Data will be listed on the spreadsheet in a random order to ensure there is no possibility of anyone, including the clinical researcher, tracing coded data back to the infant.
Data storage:
The spreadsheet of coded variables will be stored in a password protected folder accessible only to the clinical researcher. In order to move the spreadsheet to the University of Central Lancashire computer system for statistical analysis, it will be emailed in secure/encrypted form then saved on a restricted drive in a password protected folder that will only be accessible to the clinical researcher and statistician.
Information to be included on spreadsheet includes:
- Gestational age category (coded 1-4)
- Medical status - number of systems involved (coded 1-5) and types (coded 1-27)
- Full oral feeding by 37 weeks and 40 weeks (coded 1-3/1-4)
Coding:
Gestational age category:
- Extremely preterm: <28 weeks
- Very preterm: 28-31+6 weeks
- Moderate to late preterm: 32-36+6 weeks
- Term: 37 weeks+
Medical status - number of systems involved:
- None
- 1
- 2
- 3
- 4 or more
Medical status - types and combinations:
- No involvement in any of the specified systems
- Neurological only
- Respiratory only
- Gastrointestinal only
- Cardiac only
- Craniofacial only
- Neurological + respiratory
- Neurological + gastrointestinal
- Neurological + cardiac
- Neurological + craniofacial
- Respiratory + gastrointestinal
- Respiratory + cardiac
- Respiratory + craniofacial
- Gastrointestinal + cardiac
- Gastrointestinal + craniofacial
- Cardiac + craniofacial
- Neurological + respiratory + gastrointestinal
- Neurological + respiratory + cardiac
- Neurological + respiratory + craniofacial
- Neurological + gastrointestinal + cardiac
- Neurological + gastrointestinal + craniofacial
- Neurological + cardiac + craniofacial
- Respiratory + gastrointestinal + cardiac
- Respiratory + gastrointestinal + craniofacial
- Respiratory + cardiac + craniofacial
- Gastrointestinal + cardiac + craniofacial
- 4 or more systems
Slow attainment of full oral feeding (preterms only):
- Yes
- No
- Information not available (exclude from analysis)
Feeding difficulty (all babies):
- Yes - achieved oral feeding after 40 weeks but before discharge
- Yes - discharged home tube feeding
- No
- Information not available (exclude from analysis)
Operational Definitions:
Gestational age groups are based on the categories used by the World Health Organisation:
- Extremely preterm: <28 weeks
- Very preterm: 28-31+6 weeks
- Moderate to late preterm: 32-36+6 weeks
- Term: 37 weeks+
Medical status will be categorized by the number of impaired body systems from the following list: neurological, respiratory, gastrointestinal, cardiac, and craniofacial. Following a thorough literature review, these five systems have been identified as the most commonly related to feeding difficulties.
Presence/absence of involvement of these systems will be determined by the patients discharge letter on BadgerNet. This letter is completed by a medical doctor and includes a section for each of the listed systems. If a problem is listed under any of these system headings it will be recorded as a positive, regardless of severity or duration. Exceptions to this include the following: retinopathy of prematurity, transient tachypnea of the newborn, intraventricular hemorrhage grades 1-2, and brachial plexus injury with no respiratory compromise.
Slow attainment of full oral feeding is defined as inability to achieve full oral feeding by:
- 37 weeks post-menstrual age (full term)
- Discharge home (if earlier than 37 weeks) or
- Within one week of birth if born at or over 36 weeks
Feeding difficulty is defined as inability to achieve full oral feeding by:
- 40 weeks post-menstrual age (due date)
- Discharge home if earlier than 40 weeks, or
- Within one week of birth if born at or over 39 weeks.
Analysis:
Descriptive statistics and appropriate statistical tests will be used to determine the presence or absence of correlation between variables. Outcomes with the strongest correlation will be identified and analysed using a logistic regression model.
- Conditions
- Infants Admitted to Neonatal Units
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: Data will be collected retrospectively. Slow attainment of oral feeding will be determined by feeding method at 37 weeks gestational age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infants Admitted to Neonatal UnitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Edney, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867410
- Sponsor's protocol ID
- IRAS Project ID: 203827
- Status last verified
- Nov 2016
- First submitted
- 28 Jul 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Infants in a Neonatal Unit Are at Most Risk of Feeding Difficulties?
- ClinicalTrials.gov ID
- NCT02867410
- Acronym / sponsor ID
- IRAS Project ID: 203827
- Conditions
- Infants Admitted to Neonatal Units
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is known that the incidence of feeding problems is high in neonatal populations and certain patient groups appear to be particularly at risk. It is not yet known which infant groups admitted to Level 3 Neonatal Units are at most risk of feeding problems and in need of specialist feeding assessment and interventions. While many studies have examined the impact of prematurity and additional medical problems on feeding outcomes, most studies to date are limited to sub-populations, and/or do not investigate how best to identify the babies who are at most risk of feeding difficulties. Neonatal Speech and Language Therapists require information about feeding risks and outcomes for the neonatal population as a whole for caseload prioritization and to target populations most in need of specialist feeding interventions.
Babies born extremely preterm (before 28 weeks gestational age) and very low birth weight (less than 1500 grams at birth) have been identified as slower to achieve full oral feeding than those born at an older gestational age and higher birth weight. Certain medical problems have been found to correlate with feeding outcomes in preterms. Impaired respiratory function, gastrointestinal complications, neurological involvement, and heart defects have all been associated with delayed feeding progression and poor feeding outcomes.
This study aims to determine if gestational age at birth or number and type of medical conditions is the better indicator of risk of feeding disorders in infants admitted to a Level 3 neonatal unit.
Design:
Prognostic study using retrospective case note analysis.
Setting:
A Level 3 Neonatal Unit (including intensive care, high dependency, and special care) at the Royal Preston Hospital.
Procedure:
A retrospective audit of routinely collected data will be undertaken and analysed. The BadgerNet patient record management system is updated daily for all babies in neonatal units around the country. Data will be collected from the BadgerNet daily notes and discharge summary and added to a bespoke spreadsheet prior to statistical analysis. Data collection will be conducted by a member of the Royal Preston Hospital Neonatal Unit clinical team. No patient identifiable data will be collected. Data will be listed on the spreadsheet in a random order to ensure there is no possibility of anyone, including the clinical researcher, tracing coded data back to the infant.
Data storage:
The spreadsheet of coded variables will be stored in a password protected folder accessible only to the clinical researcher. In order to move the spreadsheet to the University of Central Lancashire computer system for statistical analysis, it will be emailed in secure/encrypted form then saved on a restricted drive in a password protected folder that will only be accessible to the clinical researcher and statistician.
Information to be included on spreadsheet includes:
- Gestational age category (coded 1-4)
- Medical status - number of systems involved (coded 1-5) and types (coded 1-27)
- Full oral feeding by 37 weeks and 40 weeks (coded 1-3/1-4)
Coding:
Gestational age category:
- Extremely preterm: <28 weeks
- Very preterm: 28-31+6 weeks
- Moderate to late preterm: 32-36+6 weeks
- Term: 37 weeks+
Medical status - number of systems involved:
- None
- 1
- 2
- 3
- 4 or more
Medical status - types and combinations:
- No involvement in any of the specified systems
- Neurological only
- Respiratory only
- Gastrointestinal only
- Cardiac only
- Craniofacial only
- Neurological + respiratory
- Neurological + gastrointestinal
- Neurological + cardiac
- Neurological + craniofacial
- Respiratory + gastrointestinal
- Respiratory + cardiac
- Respiratory + craniofacial
- Gastrointestinal + cardiac
- Gastrointestinal + craniofacial
- Cardiac + craniofacial
- Neurological + respiratory + gastrointestinal
- Neurological + respiratory + cardiac
- Neurological + respiratory + craniofacial
- Neurological + gastrointestinal + cardiac
- Neurological + gastrointestinal + craniofacial
- Neurological + cardiac + craniofacial
- Respiratory + gastrointestinal + cardiac
- Respiratory + gastrointestinal + craniofacial
- Respiratory + cardiac + craniofacial
- Gastrointestinal + cardiac + craniofacial
- 4 or more systems
Slow attainment of full oral feeding (preterms only):
- Yes
- No
- Information not available (exclude from analysis)
Feeding difficulty (all babies):
- Yes - achieved oral feeding after 40 weeks but before discharge
- Yes - discharged home tube feeding
- No
- Information not available (exclude from analysis)
Operational Definitions:
Gestational age groups are based on the categories used by the World Health Organisation:
- Extremely preterm: <28 weeks
- Very preterm: 28-31+6 weeks
- Moderate to late preterm: 32-36+6 weeks
- Term: 37 weeks+
Medical status will be categorized by the number of impaired body systems from the following list: neurological, respiratory, gastrointestinal, cardiac, and craniofacial. Following a thorough literature review, these five systems have been identified as the most commonly related to feeding difficulties.
Presence/absence of involvement of these systems will be determined by the patients discharge letter on BadgerNet. This letter is completed by a medical doctor and includes a section for each of the listed systems. If a problem is listed under any of these system headings it will be recorded as a positive, regardless of severity or duration. Exceptions to this include the following: retinopathy of prematurity, transient tachypnea of the newborn, intraventricular hemorrhage grades 1-2, and brachial plexus injury with no respiratory compromise.
Slow attainment of full oral feeding is defined as inability to achieve full oral feeding by:
- 37 weeks post-menstrual age (full term)
- Discharge home (if earlier than 37 weeks) or
- Within one week of birth if born at or over 36 weeks
Feeding difficulty is defined as inability to achieve full oral feeding by:
- 40 weeks post-menstrual age (due date)
- Discharge home if earlier than 40 weeks, or
- Within one week of birth if born at or over 39 weeks.
Analysis:
Descriptive statistics and appropriate statistical tests will be used to determine the presence or absence of correlation between variables. Outcomes with the strongest correlation will be identified and analysed using a logistic regression model.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants admitted to a Level 3 Neonatal Unit
Key inclusion criteria (1 listed)
- Admitted to the Royal Preston Hospital Neonatal Unit at any point during 2015
Key exclusion criteria (1 listed)
- All required data regarding their gestational age, medical status, and feeding outcome is not available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infants Admitted to Neonatal Units, run by University of Central Lancashire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah K Edney (+44 07738337413, sarah.k.edney@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016; AzTrials last refreshed its copy on 6 Nov 2026.