Preterm InfantComfortNEONCT03796312
The Effect of Tub vs Sponge Bathing on the Comfort of Premature Infants
A study testing Tub Bathing and Sponge Bathing in people with Preterm Infant and Premature Birth, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The integumentary system protects the underlying body from the external environment, such as shocks, temperature, ultraviolet radiation, chemicals, and other threats. There is a considerable body of clinical evidence highlighting the importance of the stratum corneum and its barrier functions, which are especially… Read more about this study
- Who is it for?
- Ages 34 to 36 weeks
- Conditions the study is for
- Preterm Infant, Premature Birth
- What is being tested?
- Tub Bathing and Sponge Bathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2015to 29 Nov 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 34 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All inborn infants with a gestational age of 34 weeks and 0 days to 36 weeks and 6 days (late preterm) were eligible to participate in this study.
Who cannot join
- Participants were excluded from the study if they were connected to
- a mechanical ventilator,
- if they had bathed in the last 12 hours,
- if within the first 78 hours of the postoperative period,
- had a central catheter,
- had received either a sedative and/or muscle relaxant,
- if they did not fulfill the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Tub Bathing and Sponge Bathing on Neonatal Comfort and Physiological Parameters in Late Preterm Infants: A Randomized Controlled Trial
The integumentary system protects the underlying body from the external environment, such as shocks, temperature, ultraviolet radiation, chemicals, and other threats. There is a considerable body of clinical evidence highlighting the importance of the stratum corneum and its barrier functions, which are especially beneficial for newborns. Given the dramatic transition from the aqueous womb to the dry terrestrial environment at birth, studies describing adaptations made by the skin barrier within the first month of life assume greater importance. The skin of the baby is morphologically and functionally different from the skin of adults. Neonatal skin is thinner, more fragile, and drier than adult skin; it is difficult to maintain fluid-electrolyte balance and temperature regulation. Notwithstanding, structure and function of skin continues to improve during the first months and even years of life. Special care procedures are nonetheless necessary to ensure healthy development, to protect the skin from irritation and reddening, and to help the newborn feel well. Therefore, this study, taking the form of a randomized controlled trial, aims to examine the effectiveness of tub bathing and sponge bathing on the physiological parameters (heart rate, respiration rate, oxygen saturation, body temperature) and comfort of late preterm infants. Increasing comfort and physiological stabilization in premature infants during neonatal care improves their neurophysiological development. Bathing procedures that support this development and will not expose the newborn to stress should be preferred.
Read the detailed description
Increasing comfort and physiological stabilization in premature infants during neonatal care improves their neurophysiological development. Bathing procedures that support this improves and will not expose the newborn to stress should be preferred.This study aimed to examine the effectiveness of tub bathing and sponge bathing methods on the comfort and physiological parameters of late preterm infants. The study was conducted in the Neonatal Intensive Care Unit of a university hospital in Turkey, between November 2015 and November 2016. Skin care is routinely performed between 08.00 and 09.00 in the form of sponge bathing. This research study sampled 120 stable, late preterm infants being cared for in the NICU. This sample was deemed adequate based on a sample size calculation conducted in PS Power and Sample Size Calculations (Version 3.0). Information concerning allocation was available only to the principal investigator. Participants were assigned a sequential number that was placed in an opaque, sealed envelope by the researcher who received the signed parental informed consent. When the participant was scheduled to be bathing, the envelope was opened by the researcher who then performed the test. The nurses could not be blinded to the allocation because of the nature of the intervention. However, the outcome assessment of the participants was blinded. Participats were randomly assigned to either sponge bathing or tub bathing groups. Bathing was performed anywhere from 6 to 48 hours post-birth, based on individual participant needs. Participants were subsequently placed in a preheated incubator, which varied according to the participant's weight and age. In order to compensate for such differences, the heads of all participants were placed at a height of 30 degrees in a right lateral position after bathing and they were monitored. The participants were not dressed during the observation period. After bathing, participants were left without intervention or contact for approximately 10 minutes or until settled before being assessed. The data collection instrument, the Preterm Infant Bathing Study Record, was designed specifically for this study. The instrument incorporates a number of scales for the measurement of outcome variables, physiological parameters, and demographic information (age, gender, type of delivery, gestational age, birth weight, body weight at study time, etc.). Outcome measures include neonatal comfort behavior and physiological parameters (body temperature, heart rate, oxygen saturation, respiratory rate). Those responsible for data collection were blinded as to the allocation of participants they were assessing. The ComfortNeo scale was used to measure newborns' comfort and pain intensity. Comfort was inferred based on infant behavior, which was evaluated on two separate occasions, 10 minutes before bathing and 10 minutes after bathing. Measurement took approximately 1-2 minutes. Internal consistency was measured by way of Cronbach's alpha coefficient, which was 0.94 before bathing, 0.93 after bathing for the second researcher, and 0.92 after bathing for the nurse. Kappa coefficients were approximately 0.84 for each sub-item. Thus, there was harmony between the two observers. Infant physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) were evaluated on three separate occasions (10 minutes before bathing, 15 minutes and 30 minutes after bathing).Statistical analysis was performed using SPSS 20.0 and SAS (ver.9.3), with statistical significance set at p<0.05.
Data was presented as means and standard deviations for continuous variables, and frequencies for categorical variables. For participant characteristics, such as the type of delivery and sex, a Chi-square test was applied to determine whether there were significant between-group differences. participant characteristics, such as birth weight and body weight at the time of the study, were evaluated for significant between-group differences using a one way ANOVA test. For a comparison of the different phases, measurement parameters (comfort score, heart rate, oxygen saturation, respiratory rate, body temperature) through the baths were averaged separately. Repeated measurement analysis of variance was performed to analyze both between and within-group differences, followed by the Bonferroni post-hoc test.
- Conditions
- Preterm Infant, Premature Birth
- Being tested
- Tub Bathing, Sponge Bathing
- Keywords
- Bathing, Comfort, Neonatal intensive care unit, Nursing care, Premature infant, Skin care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tub BathingBehavioural
The infant's face was washed and dried while still wrapped before being immersed. The water level in the tub was set at approximately 9-12 cm or deep enough to cover the baby's shoulders. A folded cloth towel was placed into the tub before bathing. The temperature of the bath water was controlled using a special water thermometer and adjusted to 37-38°C. The infant was held securely; the head and neck were supported on the researcher's forearm, and the shoulder was grasped using the researcher's thumb and finger. Cleaning was performed using a soft cloth and baby skin cleaner. The front and back areas were cleaned without turning the infant. The newborn was safely removed from the water and wrapped in a clean towel.
Sponge BathingBehavioural
Sponge bathing is routine care of the clinic
| Study group | Role | What they receive |
|---|---|---|
| Tub Bathing | Experimental | In this group, preterm infants were given tub bathing. Receives: Behavioral: Tub Bathing |
| Sponge Bathing | Active comparator | Separate cotton cloths were prepared for each body area in the sponge bath. The room temperature was set to 26-27°C to prevent hypothermia. The temperature of the water used for sponge bathing was set to 37-38°C. Alongside the bath, the infant was placed on a flat, protected surface and washed from a bowl of water, using the same mild cleanser. The eyes, face, and head were wiped and dried while the baby was wrapped in a blanket. The wrap was opened so that body parts could be washed, dried, and then immediately rewrapped, after which infants were diapered. Receives: Behavioral: Sponge Bathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Comfort
Data on comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing. The ComfortNeo scale was used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting. Comfort was inferred based on infant behavior 10 minutes before bathing and 10 minutes after bathing.
Measured: An average of 1 year
Secondary outcomes (4)
Heart Rate
The number of heartbeats per minute was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.
Measured: An average of 1 year
Oxygen Saturation
Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants. Pulse oximetry measures peripheral arterial oxygen saturation (%) as a surrogate marker for tissue oxygenation.
Measured: An average of 1 year
Respiration Rate
The respiration rate is the number of breaths a person takes per minute. The rate is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises.
Measured: An average of 1 year
Body Temperature
Body temperature was measured using the axillary method (under the armpit)in degrees Celsius.
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start20 Nov 2015
- Primary completion29 Nov 2016
- Study completion29 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Akdeniz 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
- Model description
- A randomized controlled two-group pre-test and repeated post-test study design were adopted. Preterm infants were randomly allocated before bathing by the researcher using a random computer-generated table to one of two groups: sponge bathing (routine care) or tub bathing. The bathing procedures were performed by the researcher. Nurses and a second researcher were blinded to the study hypotheses.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Tasdemir, Akdeniz University
- Investigators
- Emine EFE, Study director, Akdeniz University Children's Health and the Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796312
- Sponsor's protocol ID
- 455111
- Acronym
- ComfortNEO
- Status last verified
- Jan 2019
- First submitted
- 26 Dec 2018
- Last updated
- 8 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sharing plans for the current study are unknown and will be made available at a later date
Publications
Bryanton J, Walsh D, Barrett M, Gaudet D. Tub bathing versus traditional sponge bathing for the newborn. J Obstet Gynecol Neonatal Nurs. 2004 Nov-Dec;33(6):704-12. doi: 10.1177/0884217504270651.
PubMed 15561658Loring C, Gregory K, Gargan B, LeBlanc V, Lundgren D, Reilly J, Stobo K, Walker C, Zaya C. Tub bathing improves thermoregulation of the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):171-179. doi: 10.1111/j.1552-6909.2011.01332.x. Epub 2012 Feb 29.
PubMed 22375955Tasdemir HI, Efe E. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial. Int J Nurs Stud. 2019 Nov;99:103377. doi: 10.1016/j.ijnurstu.2019.06.008. Epub 2019 Jun 21.
PubMed 31442786
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tub Bathing and Sponge Bathing on Neonatal Comfort and Physiological Parameters in Late Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03796312
- Acronym / sponsor ID
- ComfortNEO / 455111
- Conditions
- Preterm Infant, Premature Birth
- Keywords
- Bathing, Comfort, Neonatal intensive care unit, Nursing care, Premature infant, Skin care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 29 Nov 2016 (actual)
- Study completion
- 29 Nov 2016 (actual)
- First posted
- 8 Jan 2019 (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.
The integumentary system protects the underlying body from the external environment, such as shocks, temperature, ultraviolet radiation, chemicals, and other threats. There is a considerable body of clinical evidence highlighting the importance of the stratum corneum and its barrier functions, which are especially beneficial for newborns. Given the dramatic transition from the aqueous womb to the dry terrestrial environment at birth, studies describing adaptations made by the skin barrier within the first month of life assume greater importance. The skin of the baby is morphologically and functionally different from the skin of adults. Neonatal skin is thinner, more fragile, and drier than adult skin; it is difficult to maintain fluid-electrolyte balance and temperature regulation. Notwithstanding, structure and function of skin continues to improve during the first months and even years of life. Special care procedures are nonetheless necessary to ensure healthy development, to protect the skin from irritation and reddening, and to help the newborn feel well. Therefore, this study, taking the form of a randomized controlled trial, aims to examine the effectiveness of tub bathing and sponge bathing on the physiological parameters (heart rate, respiration rate, oxygen saturation, body temperature) and comfort of late preterm infants. Increasing comfort and physiological stabilization in premature infants during neonatal care improves their neurophysiological development. Bathing procedures that support this development and will not expose the newborn to stress should be preferred.
Detailed description
Increasing comfort and physiological stabilization in premature infants during neonatal care improves their neurophysiological development. Bathing procedures that support this improves and will not expose the newborn to stress should be preferred.This study aimed to examine the effectiveness of tub bathing and sponge bathing methods on the comfort and physiological parameters of late preterm infants. The study was conducted in the Neonatal Intensive Care Unit of a university hospital in Turkey, between November 2015 and November 2016. Skin care is routinely performed between 08.00 and 09.00 in the form of sponge bathing. This research study sampled 120 stable, late preterm infants being cared for in the NICU. This sample was deemed adequate based on a sample size calculation conducted in PS Power and Sample Size Calculations (Version 3.0). Information concerning allocation was available only to the principal investigator. Participants were assigned a sequential number that was placed in an opaque, sealed envelope by the researcher who received the signed parental informed consent. When the participant was scheduled to be bathing, the envelope was opened by the researcher who then performed the test. The nurses could not be blinded to the allocation because of the nature of the intervention. However, the outcome assessment of the participants was blinded. Participats were randomly assigned to either sponge bathing or tub bathing groups. Bathing was performed anywhere from 6 to 48 hours post-birth, based on individual participant needs. Participants were subsequently placed in a preheated incubator, which varied according to the participant's weight and age. In order to compensate for such differences, the heads of all participants were placed at a height of 30 degrees in a right lateral position after bathing and they were monitored. The participants were not dressed during the observation period. After bathing, participants were left without intervention or contact for approximately 10 minutes or until settled before being assessed. The data collection instrument, the Preterm Infant Bathing Study Record, was designed specifically for this study. The instrument incorporates a number of scales for the measurement of outcome variables, physiological parameters, and demographic information (age, gender, type of delivery, gestational age, birth weight, body weight at study time, etc.). Outcome measures include neonatal comfort behavior and physiological parameters (body temperature, heart rate, oxygen saturation, respiratory rate). Those responsible for data collection were blinded as to the allocation of participants they were assessing. The ComfortNeo scale was used to measure newborns' comfort and pain intensity. Comfort was inferred based on infant behavior, which was evaluated on two separate occasions, 10 minutes before bathing and 10 minutes after bathing. Measurement took approximately 1-2 minutes. Internal consistency was measured by way of Cronbach's alpha coefficient, which was 0.94 before bathing, 0.93 after bathing for the second researcher, and 0.92 after bathing for the nurse. Kappa coefficients were approximately 0.84 for each sub-item. Thus, there was harmony between the two observers. Infant physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) were evaluated on three separate occasions (10 minutes before bathing, 15 minutes and 30 minutes after bathing).Statistical analysis was performed using SPSS 20.0 and SAS (ver.9.3), with statistical significance set at p<0.05.
Data was presented as means and standard deviations for continuous variables, and frequencies for categorical variables. For participant characteristics, such as the type of delivery and sex, a Chi-square test was applied to determine whether there were significant between-group differences. participant characteristics, such as birth weight and body weight at the time of the study, were evaluated for significant between-group differences using a one way ANOVA test. For a comparison of the different phases, measurement parameters (comfort score, heart rate, oxygen saturation, respiratory rate, body temperature) through the baths were averaged separately. Repeated measurement analysis of variance was performed to analyze both between and within-group differences, followed by the Bonferroni post-hoc test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled two-group pre-test and repeated post-test study design were adopted. Preterm infants were randomly allocated before bathing by the researcher using a random computer-generated table to one of two groups: sponge bathing (routine care) or tub bathing. The bathing procedures were performed by the researcher. Nurses and a second researcher were blinded to the study hypotheses.
| Arm | Type | Receives |
|---|---|---|
| Tub Bathing | Experimental | Behavioral: Tub BathingIn this group, preterm infants were given tub bathing. |
| Sponge Bathing | Active comparator | Behavioral: Sponge BathingSeparate cotton cloths were prepared for each body area in the sponge bath. The room temperature was set to 26-27°C to prevent hypothermia. The temperature of the water used for sponge bathing was set to 37-38°C. Alongside the bath, the infant was placed on a flat, protected surface and washed from a bowl of water, using the same mild cleanser. The eyes, face, and head were wiped and dried while the baby was wrapped in a blanket. The wrap was opened so that body parts could be washed, dried, and then immediately rewrapped, after which infants were diapered. |
Who may qualify
- Ages
- 34 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All inborn infants with a gestational age of 34 weeks and 0 days to 36 weeks and 6 days (late preterm) were eligible to participate in this study.
Key exclusion criteria (7 listed)
- Participants were excluded from the study if they were connected to
- a mechanical ventilator,
- if they had bathed in the last 12 hours,
- if within the first 78 hours of the postoperative period,
- had a central catheter,
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 |
|---|---|---|
| Tub BathingThe infant's face was washed and dried while still wrapped before being immersed. The water level in the tub was set at approximately 9-12 cm or deep enough to cover the baby's shoulders. A folded cloth towel was placed into the tub before bathing. The temperature of the bath water was controlled using a special water thermometer and adjusted to 37-38°C. The infant was held securely; the head and neck were supported on the researcher's forearm, and the shoulder was grasped using the researcher's thumb and finger. Cleaning was performed using a soft cloth and baby skin cleaner. The front and back areas were cleaned without turning the infant. The newborn was safely removed from the water and wrapped in a clean towel. | Behavioural | Tub Bathing |
| Sponge BathingSponge bathing is routine care of the clinic | Behavioural | Sponge Bathing |
Primary outcome
Neonatal Comfort
Time frame: An average of 1 year
Data on comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing. The ComfortNeo scale was used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting. Comfort was inferred based on infant behavior 10 minutes before bathing and 10 minutes after bathing.
4 secondary outcomes
Heart Rate
Time frame: An average of 1 year
Oxygen Saturation
Time frame: An average of 1 year
Respiration Rate
Time frame: An average of 1 year
Body Temperature
Time frame: An average of 1 year
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 8 Jan 2019.
- Background: PubMed 15561658Bryanton J, Walsh D, Barrett M, Gaudet D. Tub bathing versus traditional sponge bathing for the newborn. J Obstet Gynecol Neonatal Nurs. 2004 Nov-Dec;33(6):704-12. doi: 10.1177/0884217504270651.
- Background: PubMed 22375955Loring C, Gregory K, Gargan B, LeBlanc V, Lundgren D, Reilly J, Stobo K, Walker C, Zaya C. Tub bathing improves thermoregulation of the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):171-179. doi: 10.1111/j.1552-6909.2011.01332.x. Epub 2012 Feb 29.
- Derived from this study: PubMed 31442786Tasdemir HI, Efe E. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial. Int J Nurs Stud. 2019 Nov;99:103377. doi: 10.1016/j.ijnurstu.2019.06.008. Epub 2019 Jun 21.
- Individual participant dataSharing planned: No. The data sharing plans for the current study are unknown and will be made available at a later date
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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.
Emine EFE study director
Akdeniz University Children's Health and the Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tub Bathing and Sponge Bathing in people with Preterm Infant and Premature Birth, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 8 Jan 2019. 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 Turkey (Türkiye). 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?
Neonatal Comfort (time frame: An average of 1 year). 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 NCT03796312, which also lists 3 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 8 Jan 2019.