CryingNCT01513226
Cycled Light and Crying of Preterm Infants
A study testing Cycled light in people with Crying and Sleep, run by University Children's Hospital, Zurich.
Trial summary
This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Cycled light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Sep 2008
- 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
- very preterm infants (≤ 32 0/7 weeks gestational age, GA)
Who cannot join
- major cerebral injuries such as intraventricular haemorrhage grade III (according to Papile 16) or periventricular leukomalacia or venous infarction (according to Govaert and de Vries 17) diagnosed by cranial ultrasound
- retinopathy of prematurity grade III and IV
- congenital malformations
- small for gestational age (birth weight < 3rd percentile)
- prenatal infections
- intrauterine drug exposure
About this study
Official title: Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants
This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.
- Being tested
- Cycled light
- Keywords
- cycled light, dim light, circadian rhythm, actigraphy, sleep, premature infant
- Medical subject headings
- Crying, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycled lightOther
lights on at daytime, lights off at nighttime
| Study group | Role | What they receive |
|---|---|---|
| Dim light | Experimental | Day and nighttime dim light conditions Receives: Other: Cycled light |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean duration and change over time for total duration per 24 hours for crying variables
mean duration per 24 hours for following variables: content, fussing, crying, unsoothable crying change over time, measured at 5 and 11 weeks corrected age
measured by diary
Measured: 5 and 11 weeks corrected age
Secondary outcomes (3)
mean sleep duration per 24 hours and change over time
mean sleep duration per 24 hours measured by sleep diary measured at 5, 11 and 25 weeks corrected age, for adressing change over time
Measured: 5,11 and 25 weeks corrected age
mean weight gain per day
mean weight gaing per day during hospital stay.
Measured: during hospital stay
mean activity count per 24 hours and change over time
mean activity count per 24 hours measured by actigraph recordings measured at three time points, 5, 11 and 25 weeks corrected age to adress change over time
Measured: 5, 11, and 25 weeks corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJun 2006
- Primary completionJan 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CryingStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oskar Jenni, MD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513226
- Sponsor's protocol ID
- CH-160.7.002.920-3
- Status last verified
- Jan 2012
- First submitted
- 11 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Very preterm infants show earlier emergence of 24-hour sleep-wake rhythms compared to term infants. Early Hum Dev. 2015 Jan;91(1):37-42. doi: 10.1016/j.earlhumdev.2014.11.002. Epub 2014 Nov 27.
PubMed 25460255Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Cycled light exposure reduces fussing and crying in very preterm infants. Pediatrics. 2012 Jul;130(1):e145-51. doi: 10.1542/peds.2011-2671. Epub 2012 Jun 11.
PubMed 22689866
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT01513226
- Acronym / sponsor ID
- CH-160.7.002.920-3
- Keywords
- cycled light, dim light, circadian rhythm, actigraphy, sleep, premature infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Jan 2012 (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.
This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dim light | Experimental | Other: Cycled lightDay and nighttime dim light conditions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- very preterm infants (≤ 32 0/7 weeks gestational age, GA)
Key exclusion criteria (6 listed)
- major cerebral injuries such as intraventricular haemorrhage grade III (according to Papile 16) or periventricular leukomalacia or venous infarction (according to Govaert and de Vries 17) diagnosed by cranial ultrasound
- retinopathy of prematurity grade III and IV
- congenital malformations
- small for gestational age (birth weight < 3rd percentile)
- prenatal infections
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 |
|---|---|---|
| Cycled lightlights on at daytime, lights off at nighttime | Other | Dim light |
Primary outcome
mean duration and change over time for total duration per 24 hours for crying variables
Time frame: 5 and 11 weeks corrected age
mean duration per 24 hours for following variables: content, fussing, crying, unsoothable crying change over time, measured at 5 and 11 weeks corrected age measured by diary
3 secondary outcomes
mean sleep duration per 24 hours and change over time
Time frame: 5,11 and 25 weeks corrected age
mean weight gain per day
Time frame: during hospital stay
mean activity count per 24 hours and change over time
Time frame: 5, 11, and 25 weeks corrected age
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 20 Jan 2012.
- Derived from this study: PubMed 25460255Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Very preterm infants show earlier emergence of 24-hour sleep-wake rhythms compared to term infants. Early Hum Dev. 2015 Jan;91(1):37-42. doi: 10.1016/j.earlhumdev.2014.11.002. Epub 2014 Nov 27.
- Derived from this study: PubMed 22689866Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Cycled light exposure reduces fussing and crying in very preterm infants. Pediatrics. 2012 Jul;130(1):e145-51. doi: 10.1542/peds.2011-2671. Epub 2012 Jun 11.
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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.
Oskar Jenni, MD principal investigator
University Children's Hospital, Zurich
Questions about this trial
What is this clinical trial studying?
A study testing Cycled light in people with Crying and Sleep, run by University Children's Hospital, Zurich.
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 6 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 20 Jan 2012. 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.
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?
mean duration and change over time for total duration per 24 hours for crying variables (time frame: 5 and 11 weeks corrected age). 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 NCT01513226, which also lists 2 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 20 Jan 2012.