Physiologic ChangesPhase 2/3NCT01833091
Creating an Artificial Night on Physiological Changes in Preterm Infants
A Phase 2/3 study testing artificial night in people with Physiologic Changes, run by Mashhad University of Medical Sciences.
Trial summary
Effects of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants. Introduction:Nowdays,with medical advances in intensive care increased chance of survival in premature infants.One of the major concerns exposure to high light levels in neonate \& subsequent it is… Read more about this study
- Who is it for?
- Ages 30 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Physiologic Changes
- What is being tested?
- artificial night
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Oct 2012
- Phase
- Phase 2/3
- 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 30 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature newborn infants with gestational age of 30-34 weeks Birth weight of 1200-2200g Taking care and supervision in the incubator to measure weight and grow up Keeping the axillary temperature in the range of 36-37° C Keeping the heart rate in the range of 100 to 160 beats per minute Breast feeding through a nasogastric tube or gastric orally Healthy infants without congenital anomalies No history of taking specific drugs or alcohol by mother during the pregnancy. Mother's lack of addiction
Who cannot join
- Illness of the infant (affecting with secondary sepsis, seizures; increased or decreased blood pressure, successive apnea, feeding intolerance or feeding stoppage) Starting phototherapy Discharge of the infant earlier than 10 days Parents' lack of consent with the study
About this study
Effects of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants.
Introduction:Nowdays,with medical advances in intensive care increased chance of survival in premature infants.One of the major concerns exposure to high light levels in neonate \& subsequent it is increase in metabolism rate.So,this study was conducted to determine the effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants.
Methods: This is a randomized clinical trial dual group study, 38 preterm infants (gestational age of 30-34weeks)due to prematurity hospitalized at Ghaem NICU,were evaluated within 10 days. Infants were divided into two groups of 1200-1700 and 1701-2200g based on the weight and the weight of each group were randomized into artificial night(dark period was from 19 to 7 during incubator was covered with linen cloth \& light period was from 7 to 19 removed the cover) and control groups(continuous lighting). Mothers \& infants through questionnaires,interviews,observation \& document completion, changes in physiologic \& weight befor entering the study \& then physiologic changes twice a day,weight \& feeding tolerance were collected daily.Data were analyzed using spss v.16 software.
- Conditions
- Physiologic Changes
- Being tested
- artificial night
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial nightOther
Also called intervention
Infants in the intervention group received light cyclic with pattern 12 hours. Light period was from 7 to 19 during which the infants were put in the normal environmental light and dark period was from 19 to 7 during which was the infants' incubator was covered with linen cloth. The vital signsand \& arterial oxygen saturation of the infants in the intervention group were controlled before covering the incubator i.e. at 19. Also, the infant's vital signs were again monitored at 7 am.The infant weighed in every day at 7 am during the 10 days of study. Feeding tolerance was daily determined at 8 am, using nasogastric tube or orogastric tube to control residue as well as to review the presence or absence of abdominal distention, vomiting.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | creat light period 12 hours with cover on incubator Receives: Other: artificial night |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants
physiological changes including:systolic blood pressure \& diastolic blood pressure(mm/hg),resoiratory rate(number of minutes),pulse rate(beats per minute), temperature(° C),arterial oxygen saturation(percent),daily weighting \& comparing it with the previous days(gram),feeding tolerance(residual volume,vomiting,abdominal distention)
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionOct 2012
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 Physiologic ChangesStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, vajihe sanadgol, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833091
- Sponsor's protocol ID
- Artificial Night
- Status last verified
- Mar 2013
- First submitted
- 10 Apr 2013
- Last updated
- 16 Apr 2013
- Results posted
- No
Publications
Morag I, Xiao YT, Bruschettini M. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD006982. doi: 10.1002/14651858.CD006982.pub5.
PubMed 39699174
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating an Artificial Night on Physiological Changes in Preterm Infants
- ClinicalTrials.gov ID
- NCT01833091
- Acronym / sponsor ID
- Artificial Night
- Conditions
- Physiologic Changes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Apr 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.
Effects of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants.
Introduction:Nowdays,with medical advances in intensive care increased chance of survival in premature infants.One of the major concerns exposure to high light levels in neonate \& subsequent it is increase in metabolism rate.So,this study was conducted to determine the effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants.
Methods: This is a randomized clinical trial dual group study, 38 preterm infants (gestational age of 30-34weeks)due to prematurity hospitalized at Ghaem NICU,were evaluated within 10 days. Infants were divided into two groups of 1200-1700 and 1701-2200g based on the weight and the weight of each group were randomized into artificial night(dark period was from 19 to 7 during incubator was covered with linen cloth \& light period was from 7 to 19 removed the cover) and control groups(continuous lighting). Mothers \& infants through questionnaires,interviews,observation \& document completion, changes in physiologic \& weight befor entering the study \& then physiologic changes twice a day,weight \& feeding tolerance were collected daily.Data were analyzed using spss v.16 software.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: artificial nightcreat light period 12 hours with cover on incubator |
| control | No intervention | – |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature newborn infants with gestational age of 30-34 weeks Birth weight of 1200-2200g Taking care and supervision in the incubator to measure weight and grow up Keeping the axillary temperature in the range of 36-37° C Keeping the heart rate in the range of 100 to 160 beats per minute Breast feeding through a nasogastric tube or gastric orally Healthy infants without congenital anomalies No history of taking specific drugs or alcohol by mother during the pregnancy. Mother's lack of addiction
Key exclusion criteria (1 listed)
- Illness of the infant (affecting with secondary sepsis, seizures; increased or decreased blood pressure, successive apnea, feeding intolerance or feeding stoppage) Starting phototherapy Discharge of the infant earlier than 10 days Parents' lack of consent with the study
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 |
|---|---|---|
| artificial nightAlso: interventionInfants in the intervention group received light cyclic with pattern 12 hours. Light period was from 7 to 19 during which the infants were put in the normal environmental light and dark period was from 19 to 7 during which was the infants' incubator was covered with linen cloth. The vital signsand \& arterial oxygen saturation of the infants in the intervention group were controlled before covering the incubator i.e. at 19. Also, the infant's vital signs were again monitored at 7 am.The infant weighed in every day at 7 am during the 10 days of study. Feeding tolerance was daily determined at 8 am, using nasogastric tube or orogastric tube to control residue as well as to review the presence or absence of abdominal distention, vomiting. | Other | intervention |
Primary outcome
effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants
Time frame: 1 years
physiological changes including:systolic blood pressure \& diastolic blood pressure(mm/hg),resoiratory rate(number of minutes),pulse rate(beats per minute), temperature(° C),arterial oxygen saturation(percent),daily weighting \& comparing it with the previous days(gram),feeding tolerance(residual volume,vomiting,abdominal distention)
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 16 Apr 2013.
- Derived from this study: PubMed 39699174Morag I, Xiao YT, Bruschettini M. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD006982. doi: 10.1002/14651858.CD006982.pub5.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing artificial night in people with Physiologic Changes, run by Mashhad University of Medical Sciences.
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 1 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 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants (time frame: 1 years). 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 NCT01833091, 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 16 Apr 2013.