Feeding IntoleranceNCT02149407
Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants
A study testing Glycerin and Rectal stimulation in people with Feeding Intolerance, run by King Saud Medical City at 2 sites in Saudi Arabia.
Trial summary
Feeding intolerance is a common problem in preterm infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Feeding Intolerance
- What is being tested?
- Glycerin and Rectal stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- May 2014to Aug 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants with birth weight equal or less than 1500 g
Who cannot join
- Significant congenital malformations
- Severity of illness such that death is likely in the first few days after birth
Trial locations and contacts
2 sites in 1 country.
Jasim Anabrees contact
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Saud Medical City
Riyadh
Latifa Almahmoud, latifa369@yahoo.com
latifa Almahmoud
- Not yet recruiting
Sulaiman Al Habib Medical Group
Riyadh
Jasim Anabrees, FRCPCH, jasim1800@yahoo.com
Jasim Anabrees, FRCPCH
About this study
Official title: Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants
Feeding intolerance is a common problem in preterm infants.
- Conditions
- Feeding Intolerance
- Being tested
- Glycerin, Rectal stimulation, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycerinDrug
Also called Glycerine
Glycerin group "GG" will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery.
Rectal stimulationProcedure or surgery
Rectal stimulation "SG" by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall.
ControlOther
Control group "CG" will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Glycerin group (GG) | Active comparator | Glycerin group "GG" will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery. Receives: Drug: Glycerin |
| Rectal stimulation group (SG) | Active comparator | Rectal stimulation "SG" by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall. Receives: Procedure: Rectal stimulation |
| Control group (CG) | Sham comparator | Control group "CG" will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full feeding (days)
Days to achieve full enteral feeding
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes (5)
Incidence of feeding intolerance
Feeding intolerance defined as feeding withheld, discontinued, or decreased because the infant was not tolerating enteral feedings.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Incidence of necrotizing enterocolitis (NEC)
Necrotizing enterocolitis (NEC) defined as per Bell's staging.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Incidence of proven late onset infection
Incidence of proven late onset infection defined as clinical signs in addition to positive blood culture beyond 72 hours of age.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Incidence of hyperbilirubinemia
Incidence of hyperbilirubinemia defined as level of bilirubin requiring treatment with phototherapy according to the bilirubin chart used in the participating unit.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Length of hospital stay (days)
Measured: At discharge from hospital, an expected average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding IntoleranceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud Medical City
- Sponsor type
- Other government
- Collaborators
- Sulaiman Al Habib Medical Group- Arrayan Hospital
- Responsible party
- Sponsor
- Investigators
- Latifa Almahmoud, MD, Study chair, KSMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149407
- Sponsor's protocol ID
- 0752
- Status last verified
- Apr 2015
- First submitted
- 20 May 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT02149407
- Acronym / sponsor ID
- 0752
- Conditions
- Feeding Intolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- King Saud Medical CityOther government
- Collaborators
- Sulaiman Al Habib Medical Group- Arrayan Hospital
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 29 May 2014 (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 intolerance is a common problem in preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glycerin group (GG) | Active comparator | Drug: GlycerinGlycerin group "GG" will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery. |
| Rectal stimulation group (SG) | Active comparator | Procedure: Rectal stimulationRectal stimulation "SG" by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall. |
| Control group (CG) | Sham comparator | Other: ControlControl group "CG" will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Preterm infants with birth weight equal or less than 1500 g
Key exclusion criteria (2 listed)
- Significant congenital malformations
- Severity of illness such that death is likely in the first few days after birth
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 |
|---|---|---|
| GlycerinAlso: GlycerineGlycerin group "GG" will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery. | Drug | Glycerin group (GG) |
| Rectal stimulationRectal stimulation "SG" by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall. | Procedure or surgery | Rectal stimulation group (SG) |
| ControlControl group "CG" will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes. | Other | Control group (CG) |
Primary outcome
Time to full feeding (days)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Days to achieve full enteral feeding
5 secondary outcomes
Incidence of feeding intolerance
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Incidence of necrotizing enterocolitis (NEC)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Incidence of proven late onset infection
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Incidence of hyperbilirubinemia
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Length of hospital stay (days)
Time frame: At discharge from hospital, an expected average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Related trials for Feeding Intolerance
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Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
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Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
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Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
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Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
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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.
Jasim Anabrees contact
Latifa Almahmoud, MD study chair
KSMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycerin and Rectal stimulation in people with Feeding Intolerance, run by King Saud Medical City at 2 sites in Saudi Arabia.
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 2 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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. Some participants in this study may receive a placebo. 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 Jasim Anabrees (jasim1800@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to full feeding (days) (time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks). 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 3 Apr 2015.