Preterm InfantpretermfoodNCT03214744
Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants
An observational study of Preterm Infant, run by Assiut University at 1 site in Egypt.
Trial summary
Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants Read more about this study
- Who is it for?
- Ages 1 week to 15 weeks
- Conditions the study is for
- Preterm Infant
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- May 2018to Jun 2019
- 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 week to 15 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonates (<36 weeks)
Who may be able to join
- All preterm neonates admitted to NICU with gestational age less than 36 weeks, and haemodynamically stable
Who cannot join
- gastrointestinal tract anomalies,
- haemodynamically unstable infants,
- gestatinal age equal or more than 36 weeks,
- preterms who develop NEC,
- preterms on mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants
Read the detailed description
Rapid feeding advancement achieves full enteral volume of feedings earlier than the slower advancement.They received significantly fewer days of parenteral nutrition, exhibited a shorter time to regain birth weight and shorter duration of hospital stay. The incidence of NEC and the number of episodes of feeding intolerance were not significantly different between rapid and slow advancement. while the incidence of culture-proven late onset sepsis was significantly less in infants receiving a rapid feeding advancement
- Conditions
- Preterm Infant
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of entral feeding on preterm
-Length of hospital stay.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study startMay 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Makrm Riad, Assiut University
- Investigators
- John J Smith, Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214744
- Sponsor's protocol ID
- 17100036
- Acronym
- pretermfood
- Status last verified
- Jul 2017
- First submitted
- 9 Jul 2017
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pike K, Brocklehurst P, Jones D, Kenyon S, Salt A, Taylor D, Marlow N. Outcomes at 7 years for babies who developed neonatal necrotising enterocolitis: the ORACLE Children Study. Arch Dis Child Fetal Neonatal Ed. 2012 Sep;97(5):F318-22. doi: 10.1136/fetalneonatal-2011-300244.
PubMed 22933088
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants
- ClinicalTrials.gov ID
- NCT03214744
- Acronym / sponsor ID
- pretermfood / 17100036
- Conditions
- Preterm Infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 12 Jul 2017 (actual)
- 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.
Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants
Detailed description
Rapid feeding advancement achieves full enteral volume of feedings earlier than the slower advancement.They received significantly fewer days of parenteral nutrition, exhibited a shorter time to regain birth weight and shorter duration of hospital stay. The incidence of NEC and the number of episodes of feeding intolerance were not significantly different between rapid and slow advancement. while the incidence of culture-proven late onset sepsis was significantly less in infants receiving a rapid feeding advancement
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 week to 15 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates (<36 weeks)
Key inclusion criteria (1 listed)
- All preterm neonates admitted to NICU with gestational age less than 36 weeks, and haemodynamically stable
Key exclusion criteria (5 listed)
- gastrointestinal tract anomalies,
- haemodynamically unstable infants,
- gestatinal age equal or more than 36 weeks,
- preterms who develop NEC,
- preterms on mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effect of entral feeding on preterm
Time frame: six months
-Length of hospital stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Background: PubMed 22933088Pike K, Brocklehurst P, Jones D, Kenyon S, Salt A, Taylor D, Marlow N. Outcomes at 7 years for babies who developed neonatal necrotising enterocolitis: the ORACLE Children Study. Arch Dis Child Fetal Neonatal Ed. 2012 Sep;97(5):F318-22. doi: 10.1136/fetalneonatal-2011-300244.
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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.
John J Smith principal investigator
National Institutes of Health Clinical Center (CC)
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 Preterm Infant, run by Assiut University at 1 site in Egypt.
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 5 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 17 Jul 2017. 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 Egypt. 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 professor Mohamed Mahrous Sayed (01003486595, Eltellawy270@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of entral feeding on preterm (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03214744, which also lists 1 linked publication.
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 17 Jul 2017.