Neonatal Procedural PainNCT01894659
Oral Sucrose Versus Glucose for Procedural Pain in Premature Neonates
A study testing 24% oral sucrose and 30% oral glucose in people with Neonatal Procedural Pain, run by Loma Linda University at 1 site in United States.
Trial summary
Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedures (TDPs) that cause pain. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Neonatal Procedural Pain
- What is being tested?
- 24% oral sucrose and 30% oral glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 31 Jul 2020
- 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 Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Potential subjects are premature infants ≤ 34 weeks gestation and ≤ 7 days of age postnatally
Who cannot join
- requirement for surgery
- intraventricular hemorrhage (IVH) ≥ grade 3
- neonates on medications such as morphine, fentanyl, versed, muscle relaxants, phenobarbital, or dilantin,
- renal injury (plasma creatinine > 1 mg/dl,
- severe cyanotic heart disease or severe respiratory distress,
- known abdominal wall or intestinal anomaly or injury (NEC),
- chromosomal anomaly and (8) facial anomaly
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedures (TDPs) that cause pain. Through our NIH funded research, we made the novel observation that exposure to a single TDP can significantly increase ATP utilization and oxidative stress, as evidenced by increased plasma levels of hypoxanthine, uric acid and malondialdehyde in neonates exposed to TDPs as compared to controls (no TDP). Because neonates are exposed to numerous TDPs, it is relevant to explore the energy costs of repeated exposures to painful procedures, an important information that is currently not known, as the effect of this cumulative metabolic dysfunction could result in potentially treatable or preventable cell injury.
Oral sucrose analgesia is frequently given to relieve procedural pain in neonates on the basis of its effect on behavioral and physiological pain scores. However, we found, through our prospective, randomized, double blind study funded by NIH, that although oral sucrose significantly reduced pain scores, its administration before a single TDP (heel lance) significantly increased ATP utilization. This is evidenced by higher plasma concentrations of hypoxanthine and uric acid in neonates given sucrose compared to control neonates (no TDP, no sucrose) or neonates just given a pacifier. These novel findings raise concern because preterm neonates have limited ATP stores and are susceptible to cell injury due to ATP depletion. In addition, it raises the relevant concern: If a single dose of oral sucrose can alter ATP metabolism, what are the effects of exposure to multiple doses of oral sucrose? More importantly, what is the effect of multiple TDPs and/or multiple oral sucrose dosages on ATP utilization, oxidative stress and cell injury? This application will also explore the effect of 30% oral glucose, another sweet solution currently used to relieve pain, on ATP metabolism.
In this study, we will test the general hypothesis that exposure to multiple TDPs and/or multiple doses of oral sucrose analgesia compared to oral glucose or standard care, alter biochemical markers of ATP utilization, oxidative stress and cell injury. We will use a prospective randomized clinical research design to test this hypothesis during days of life 3-7 of human premature neonates. Increased ATP utilization will be quantified by concentrations of hypoxanthine, xanthine and uric acid measured using HPLC. Oxidative stress will be quantified by concentrations of allantoin using gas chromatography/mass spectroscopy, and cell injury will be quantified through urinary concentration of intestinal fatty acid binding protein, an early marker of enterocyte injury. Data from this application will provide insight into the cellular and biochemical effects of repetitive and accumulated TDPs and/or multiple doses of oral sucrose. With this knowledge, we will propose and test innovative strategies that will not only decrease pain but also will prevent cell injury or cell death.
- Conditions
- Neonatal Procedural Pain
- Being tested
- 24% oral sucrose, 30% oral glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24% oral sucroseOther
30% oral glucoseOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Neonates randomized to this arm will receive the standard of practice at Loma Linda University NICU. |
| 24% oral sucrose with pacifier | Experimental | Neonates randomized to this arm will receive 24% sucrose before every painful procedure on days of life 3-7 in the NICU. Receives: Other: 24% oral sucrose |
| 30% oral glucose with pacifier | Experimental | Neonates randomized to this arm will receive 30% oral glucose before every painful procedure on days of life 3-7. Receives: Other: 30% oral glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will determine the relationship between oral sucrose or glucose on urinary markers of ATP utilization, oxidative stress and cell injury compared to multiple doses of oral glucose (30%) or to control group
To quantify ATP utilization, we will measure urinary concentrations of Hx, Xa, UA. To quantify oxidative stress, we will measure urinary concentrations of allantoin. To quantify cell injury, we will measure urinary concentrations of intestinal fatty acid binding protein.
Measured: Day of life 3-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startFeb 2014
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Procedural PainStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danilyn Angeles, PhD, Loma Linda University
- Investigators
- Danilyn Angeles, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894659
- Sponsor's protocol ID
- 5130117
- Status last verified
- Aug 2020
- First submitted
- 1 Jul 2013
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Sucrose Versus Glucose for Procedural Pain in Premature Neonates
- ClinicalTrials.gov ID
- NCT01894659
- Acronym / sponsor ID
- 5130117
- Conditions
- Neonatal Procedural Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 10 Jul 2013 (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.
Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedures (TDPs) that cause pain. Through our NIH funded research, we made the novel observation that exposure to a single TDP can significantly increase ATP utilization and oxidative stress, as evidenced by increased plasma levels of hypoxanthine, uric acid and malondialdehyde in neonates exposed to TDPs as compared to controls (no TDP). Because neonates are exposed to numerous TDPs, it is relevant to explore the energy costs of repeated exposures to painful procedures, an important information that is currently not known, as the effect of this cumulative metabolic dysfunction could result in potentially treatable or preventable cell injury.
Oral sucrose analgesia is frequently given to relieve procedural pain in neonates on the basis of its effect on behavioral and physiological pain scores. However, we found, through our prospective, randomized, double blind study funded by NIH, that although oral sucrose significantly reduced pain scores, its administration before a single TDP (heel lance) significantly increased ATP utilization. This is evidenced by higher plasma concentrations of hypoxanthine and uric acid in neonates given sucrose compared to control neonates (no TDP, no sucrose) or neonates just given a pacifier. These novel findings raise concern because preterm neonates have limited ATP stores and are susceptible to cell injury due to ATP depletion. In addition, it raises the relevant concern: If a single dose of oral sucrose can alter ATP metabolism, what are the effects of exposure to multiple doses of oral sucrose? More importantly, what is the effect of multiple TDPs and/or multiple oral sucrose dosages on ATP utilization, oxidative stress and cell injury? This application will also explore the effect of 30% oral glucose, another sweet solution currently used to relieve pain, on ATP metabolism.
In this study, we will test the general hypothesis that exposure to multiple TDPs and/or multiple doses of oral sucrose analgesia compared to oral glucose or standard care, alter biochemical markers of ATP utilization, oxidative stress and cell injury. We will use a prospective randomized clinical research design to test this hypothesis during days of life 3-7 of human premature neonates. Increased ATP utilization will be quantified by concentrations of hypoxanthine, xanthine and uric acid measured using HPLC. Oxidative stress will be quantified by concentrations of allantoin using gas chromatography/mass spectroscopy, and cell injury will be quantified through urinary concentration of intestinal fatty acid binding protein, an early marker of enterocyte injury. Data from this application will provide insight into the cellular and biochemical effects of repetitive and accumulated TDPs and/or multiple doses of oral sucrose. With this knowledge, we will propose and test innovative strategies that will not only decrease pain but also will prevent cell injury or cell death.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Neonates randomized to this arm will receive the standard of practice at Loma Linda University NICU. |
| 24% oral sucrose with pacifier | Experimental | Other: 24% oral sucroseNeonates randomized to this arm will receive 24% sucrose before every painful procedure on days of life 3-7 in the NICU. |
| 30% oral glucose with pacifier | Experimental | Other: 30% oral glucoseNeonates randomized to this arm will receive 30% oral glucose before every painful procedure on days of life 3-7. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Potential subjects are premature infants ≤ 34 weeks gestation and ≤ 7 days of age postnatally
Key exclusion criteria (7 listed)
- requirement for surgery
- intraventricular hemorrhage (IVH) ≥ grade 3
- neonates on medications such as morphine, fentanyl, versed, muscle relaxants, phenobarbital, or dilantin,
- renal injury (plasma creatinine > 1 mg/dl,
- severe cyanotic heart disease or severe respiratory distress,
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 |
|---|---|---|
| 24% oral sucrose | Other | 24% oral sucrose with pacifier |
| 30% oral glucose | Other | 30% oral glucose with pacifier |
Primary outcome
We will determine the relationship between oral sucrose or glucose on urinary markers of ATP utilization, oxidative stress and cell injury compared to multiple doses of oral glucose (30%) or to control group
Time frame: Day of life 3-7
To quantify ATP utilization, we will measure urinary concentrations of Hx, Xa, UA. To quantify oxidative stress, we will measure urinary concentrations of allantoin. To quantify cell injury, we will measure urinary concentrations of intestinal fatty acid binding protein.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
Danilyn Angeles, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24% oral sucrose and 30% oral glucose in people with Neonatal Procedural Pain, run by Loma Linda University at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 2 Sep 2020. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We will determine the relationship between oral sucrose or glucose on urinary markers of ATP utilization, oxidative stress and cell injury compared to multiple doses of oral glucose (30%) or to control group (time frame: Day of life 3-7). 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 Sep 2020.