PainPhase 4LACTEETNCT02133716
Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm
A Phase 4 study testing expressed breast milk and sucrose 24% oral in people with Pain and Premature Infant, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates. Read more about this study
- Who is it for?
- Ages 25 to 37 weeks
- Conditions the study is for
- Pain, Premature Infant, Human Milk
- What is being tested?
- expressed breast milk and sucrose 24% oral
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Oct 2014
- Phase
- Phase 4
- 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 25 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates.
- Weight less than 2500 grams.
- Feed breastfeeding (exclusive or not) or can obtain weight expressed breastmilk .
- Be informed and consent to the parents of those infants previously requested.
Who cannot join
- Maternal use of opioids or insulin-depent
- infants with invasive artificial respiration
- infants with major congenital anomalies
- infants with grade II or IV intraventricular hemorrhage or strokes
- receiving parental sedatives or vasoactive drugs
- infants with necrotizing enterocolitis
Show all 9Show fewer
- with surgical interventions
- infants in absolute diet
- infants with abstinence syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Breast Milk Expressed Versus Sucrose Relief Procedural Pain of Venipuncture in Preterm.
The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.
This is an experimental comparative study of non-inferiority randomized crossover, to be performed in Neonatal units of hospitals in the Community of Madrid.
Read more
The 54 pair of preterm that after the selection criteria are included in the study, they performed the randomization of the sequence and breast milk expressed receive oral or 24% sucrose.
The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA), 0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior to venipuncture.
The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile (PIPP) and by percent of cry.
Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.
- Conditions
- Pain, Premature Infant, Human Milk, Breastfeeding
- Being tested
- expressed breast milk, sucrose 24% oral
- Keywords
- pain, premature infant, sucrose, breastfeeding, expressed breast milk, PIPP
- Medical subject headings
- Pain, Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expressed breast milkOther
The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
A single dose prior to venipuncture of expressed breast milk given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.
sucrose 24% oralBehavioural
The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
A single dose prior to venipuncture of oral sucrose 24% given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.
| Study group | Role | What they receive |
|---|---|---|
| expressed breast milk | Experimental | A single dose of expressed breast milk was administered through a sterile syringe in the mouth 2 minutes before venopuncture to neonates, accompanied at all times provided the technique allows it to non-nutritive sucking and containment.
The doses administered: 0.1ml in infants less than 27 weeks , 0.25 ml for infants 27-31 weeks , 0.5 ml for infants 32-37 weeks. Receives: Other: expressed breast milk |
| sucrose 24% oral | Active comparator | A single dose of sucrose was administered through a sterile syringe in the mouth 2 minutes before venopuncture to neonates, accompanied at all times provided the technique allows it to non-nutritive sucking and containment.
The doses administered: 0.1ml in infants less than 27 weeks , 0.25 ml for infants 27-31 weeks , 0.5 ml for infants 32-37 weeks. Receives: Behavioral: sucrose 24% oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain neonatal
The pain neonatal will be determined by the scale Premature Infant Pain Profile (PIPP). The PIPP scale is a multidimensional measure developed to assess pain in preterm and term infants.
It consists of three behavioral indicators (facial actions: philtrum, frowning, clenched eyes), two physiological indicators (heart rate and oxygen saturation) and two measures of development (gestational age and behavioral state). Each pointer may take four values on a scale from 0 to 3, which is subsequently added to an overall score. The score range from 0 (no pain or the presence of minimal pain) to 21 (maximum pain) in preterm.
PIPP score was evaluated at 30 seconds after venopuncture Both the validity and reliability of this scale have been studied and proven in various studies.
The PIPP scale will it be monitored by skilled and experienced nurses in neonatal care.
Measured: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months
Secondary outcomes (1)
Percentage of crying
Relationship between duration procedure venipuncture and the time or duration of crying(from beginning to cry until terminated.)
Measured: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Collados Gómez, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133716
- Sponsor's protocol ID
- LACTEET
- Acronym
- LACTEET
- Status last verified
- May 2014
- First submitted
- 17 Apr 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.
PubMed 17079598Bouza H. The impact of pain in the immature brain. J Matern Fetal Neonatal Med. 2009 Sep;22(9):722-32. doi: 10.3109/14767050902926962.
PubMed 19526425Bueno M, Stevens B, de Camargo PP, Toma E, Krebs VL, Kimura AF. Breast milk and glucose for pain relief in preterm infants: a noninferiority randomized controlled trial. Pediatrics. 2012 Apr;129(4):664-70. doi: 10.1542/peds.2011-2024. Epub 2012 Mar 5.
PubMed 22392169Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Hubert P, de Saint Blanquat L, Boelle PY, Annequin D, Cimerman P, Anand KJ, Breart G. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008 Jul 2;300(1):60-70. doi: 10.1001/jama.300.1.60.
PubMed 18594041Vinall J, Grunau RE. Impact of repeated procedural pain-related stress in infants born very preterm. Pediatr Res. 2014 May;75(5):584-7. doi: 10.1038/pr.2014.16. Epub 2014 Feb 5.
PubMed 24500615Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523.
PubMed 12205254Lopez Maestro M, Melgar Bonis A, de la Cruz-Bertolo J, Perapoch Lopez J, Mosqueda Pena R, Pallas Alonso C. [Developmental centered care. Situation in Spanish neonatal units]. An Pediatr (Barc). 2014 Oct;81(4):232-40. doi: 10.1016/j.anpedi.2013.10.043. Epub 2013 Dec 2. Spanish.
PubMed 24290892Marin Gabriel MA, del Rey Hurtado de Mendoza B, Jimenez Figueroa L, Medina V, Iglesias Fernandez B, Vazquez Rodriguez M, Escudero Huedo V, Medina Malagon L. Analgesia with breastfeeding in addition to skin-to-skin contact during heel prick. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F499-503. doi: 10.1136/archdischild-2012-302921. Epub 2013 Jul 9.
PubMed 23839984Ors R, Ozek E, Baysoy G, Cebeci D, Bilgen H, Turkuner M, Basaran M. Comparison of sucrose and human milk on pain response in newborns. Eur J Pediatr. 1999 Jan;158(1):63-6. doi: 10.1007/s004310051011.
PubMed 9950311Ozdogan T, Akman I, Cebeci D, Bilgen H, Ozek E. Comparison of two doses of breast milk and sucrose during neonatal heel prick. Pediatr Int. 2010 Apr;52(2):175-9. doi: 10.1111/j.1442-200X.2009.02921.x. Epub 2009 Jul 16.
PubMed 19627552Ou-Yang MC, Chen IL, Chen CC, Chung MY, Chen FS, Huang HC. Expressed breast milk for procedural pain in preterm neonates: a randomized, double-blind, placebo-controlled trial. Acta Paediatr. 2013 Jan;102(1):15-21. doi: 10.1111/apa.12045. Epub 2012 Nov 1.
PubMed 23057434Shah PS, Herbozo C, Aliwalas LL, Shah VS. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004950. doi: 10.1002/14651858.CD004950.pub3.
PubMed 23235618Pillai Riddell RR, Racine NM, Turcotte K, Uman LS, Horton RE, Din Osmun L, Ahola Kohut S, Hillgrove Stuart J, Stevens B, Gerwitz-Stern A. Non-pharmacological management of infant and young child procedural pain. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD006275. doi: 10.1002/14651858.CD006275.pub2.
PubMed 21975752Simonse E, Mulder PG, van Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics. 2012 Apr;129(4):657-63. doi: 10.1542/peds.2011-2173. Epub 2012 Mar 5.
PubMed 22392168Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. doi: 10.1097/00002508-199603000-00004.
PubMed 8722730
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Breast Milk Expressed Versus Sucrose Relief Procedural Pain of Venipuncture in Preterm.
- ClinicalTrials.gov ID
- NCT02133716
- Acronym / sponsor ID
- LACTEET / LACTEET
- Conditions
- Pain, Premature Infant, Human Milk, Breastfeeding
- Keywords
- pain, premature infant, sucrose, breastfeeding, expressed breast milk, PIPP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 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.
The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.
This is an experimental comparative study of non-inferiority randomized crossover, to be performed in Neonatal units of hospitals in the Community of Madrid.
The 54 pair of preterm that after the selection criteria are included in the study, they performed the randomization of the sequence and breast milk expressed receive oral or 24% sucrose.
The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA), 0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior to venipuncture.
The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile (PIPP) and by percent of cry.
Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| expressed breast milk | Experimental | Other: expressed breast milkA single dose of expressed breast milk was administered through a sterile syringe in the mouth 2 minutes before venopuncture to neonates, accompanied at all times provided the technique allows it to non-nutritive sucking and containment. The doses administered: 0.1ml in infants less than 27 weeks , 0.25 ml for infants 27-31 weeks , 0.5 ml for infants 32-37 weeks. |
| sucrose 24% oral | Active comparator | Behavioral: sucrose 24% oralA single dose of sucrose was administered through a sterile syringe in the mouth 2 minutes before venopuncture to neonates, accompanied at all times provided the technique allows it to non-nutritive sucking and containment. The doses administered: 0.1ml in infants less than 27 weeks , 0.25 ml for infants 27-31 weeks , 0.5 ml for infants 32-37 weeks. |
Who may qualify
- Ages
- 25 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm neonates.
- Weight less than 2500 grams.
- Feed breastfeeding (exclusive or not) or can obtain weight expressed breastmilk .
- Be informed and consent to the parents of those infants previously requested.
Key exclusion criteria (9 listed)
- Maternal use of opioids or insulin-depent
- infants with invasive artificial respiration
- infants with major congenital anomalies
- infants with grade II or IV intraventricular hemorrhage or strokes
- receiving parental sedatives or vasoactive drugs
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 |
|---|---|---|
| expressed breast milkThe administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk. A single dose prior to venipuncture of expressed breast milk given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment. | Other | expressed breast milk |
| sucrose 24% oralThe administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk. A single dose prior to venipuncture of oral sucrose 24% given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment. | Behavioural | sucrose 24% oral |
Primary outcome
Pain neonatal
Time frame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months
The pain neonatal will be determined by the scale Premature Infant Pain Profile (PIPP). The PIPP scale is a multidimensional measure developed to assess pain in preterm and term infants. It consists of three behavioral indicators (facial actions: philtrum, frowning, clenched eyes), two physiological indicators (heart rate and oxygen saturation) and two measures of development (gestational age and behavioral state). Each pointer may take four values on a scale from 0 to 3, which is subsequently added to an overall score. The score range from 0 (no pain or the presence of minimal pain) to 21 (maximum pain) in preterm. PIPP score was evaluated at 30 seconds after venopuncture Both the validity and reliability of this scale have been studied and proven in various studies. The PIPP scale will it be monitored by skilled and experienced nurses in neonatal care.
1 secondary outcome
Percentage of crying
Time frame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months
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 18 Mar 2015.
- Background: PubMed 17079598American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.
- Background: PubMed 19526425Bouza H. The impact of pain in the immature brain. J Matern Fetal Neonatal Med. 2009 Sep;22(9):722-32. doi: 10.3109/14767050902926962.
- Background: PubMed 22392169Bueno M, Stevens B, de Camargo PP, Toma E, Krebs VL, Kimura AF. Breast milk and glucose for pain relief in preterm infants: a noninferiority randomized controlled trial. Pediatrics. 2012 Apr;129(4):664-70. doi: 10.1542/peds.2011-2024. Epub 2012 Mar 5.
- Background: PubMed 18594041Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Hubert P, de Saint Blanquat L, Boelle PY, Annequin D, Cimerman P, Anand KJ, Breart G. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008 Jul 2;300(1):60-70. doi: 10.1001/jama.300.1.60.
- Background: PubMed 24500615Vinall J, Grunau RE. Impact of repeated procedural pain-related stress in infants born very preterm. Pediatr Res. 2014 May;75(5):584-7. doi: 10.1038/pr.2014.16. Epub 2014 Feb 5.
- Background: PubMed 12205254Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523.
- Background: PubMed 24290892Lopez Maestro M, Melgar Bonis A, de la Cruz-Bertolo J, Perapoch Lopez J, Mosqueda Pena R, Pallas Alonso C. [Developmental centered care. Situation in Spanish neonatal units]. An Pediatr (Barc). 2014 Oct;81(4):232-40. doi: 10.1016/j.anpedi.2013.10.043. Epub 2013 Dec 2. Spanish.
- Background: PubMed 23839984Marin Gabriel MA, del Rey Hurtado de Mendoza B, Jimenez Figueroa L, Medina V, Iglesias Fernandez B, Vazquez Rodriguez M, Escudero Huedo V, Medina Malagon L. Analgesia with breastfeeding in addition to skin-to-skin contact during heel prick. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F499-503. doi: 10.1136/archdischild-2012-302921. Epub 2013 Jul 9.
- Background: PubMed 9950311Ors R, Ozek E, Baysoy G, Cebeci D, Bilgen H, Turkuner M, Basaran M. Comparison of sucrose and human milk on pain response in newborns. Eur J Pediatr. 1999 Jan;158(1):63-6. doi: 10.1007/s004310051011.
- Background: PubMed 19627552Ozdogan T, Akman I, Cebeci D, Bilgen H, Ozek E. Comparison of two doses of breast milk and sucrose during neonatal heel prick. Pediatr Int. 2010 Apr;52(2):175-9. doi: 10.1111/j.1442-200X.2009.02921.x. Epub 2009 Jul 16.
- Background: PubMed 23057434Ou-Yang MC, Chen IL, Chen CC, Chung MY, Chen FS, Huang HC. Expressed breast milk for procedural pain in preterm neonates: a randomized, double-blind, placebo-controlled trial. Acta Paediatr. 2013 Jan;102(1):15-21. doi: 10.1111/apa.12045. Epub 2012 Nov 1.
- Background: PubMed 23235618Shah PS, Herbozo C, Aliwalas LL, Shah VS. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004950. doi: 10.1002/14651858.CD004950.pub3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing expressed breast milk and sucrose 24% oral in people with Pain and Premature Infant, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 4 inclusion and 9 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 18 Mar 2015. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain neonatal (time frame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 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 NCT02133716, which also lists 16 linked publications.
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 18 Mar 2015.