Postnatal GrowthNCT00565357
Silicone Earplugs for VLBW Newborns in Intensive Care
A study testing Silicone Earplugs in people with Postnatal Growth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
The purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Postnatal Growth
- What is being tested?
- Silicone Earplugs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Aug 2005
- 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
- birthweight between 401 and 1500 grams
- less than 1 week of age
- parental informed consent
- availability of research personnel
Who cannot join
- terminal illness
- congenital anomalies
- syndromes associated with hearing loss
About this study
Official title: Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial
The purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. The study hypothesis was that newborns who were randomized to the earplug group would be heavier than controls at 34 weeks post-menstrual age.
- Conditions
- Postnatal Growth
- Being tested
- Silicone Earplugs, Control
- Keywords
- Postnatal Growth, Postnatal Development, Noise, Neonatal Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone EarplugsDevice
Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first
ControlOther
Standard care in the neonatal intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| E | Experimental | Not described Receives: Device: Silicone Earplugs |
| C | No intervention | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 34 weeks post-menstrual age
Secondary outcomes (8)
Length of stay in neonatal intensive care
Measured: hospital discharge
Time on mechanical ventilator
Measured: hospital discharge
Weight
Measured: 18 - 22 months of age
Length
Measured: 18 - 22 months of age
Frontal-occipital circumference
Measured: 18 - 22 months of age
Bayley Mental Developmental Index
Measured: 18 - 22 months of age
Bayley Psychomotor Developmental Index
Measured: 18 - 22 months of age
ABR Hearing Screen
Measured: hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startJun 2002
- Study completionAug 2005
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 Postnatal GrowthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert E Lasky, PhD, Principal investigator, University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565357
- Sponsor's protocol ID
- R01HD042639-01A3
- Status last verified
- Nov 2007
- First submitted
- 27 Nov 2007
- Last updated
- 29 Nov 2007
- Results posted
- No
Publications
Abou Turk C, Williams AL, Lasky RE. A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care. J Perinatol. 2009 May;29(5):358-63. doi: 10.1038/jp.2008.236. Epub 2009 Feb 5.
PubMed 19194455
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00565357
- Acronym / sponsor ID
- R01HD042639-01A3
- Conditions
- Postnatal Growth
- Keywords
- Postnatal Growth, Postnatal Development, Noise, Neonatal Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jun 2002
- Study completion
- Aug 2005 (actual)
- First posted
- 29 Nov 2007 (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 purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. The study hypothesis was that newborns who were randomized to the earplug group would be heavier than controls at 34 weeks post-menstrual age.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E | Experimental | Device: Silicone Earplugs |
| C | No intervention | Other: Control |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- birthweight between 401 and 1500 grams
- less than 1 week of age
- parental informed consent
- availability of research personnel
Key exclusion criteria (3 listed)
- terminal illness
- congenital anomalies
- syndromes associated with hearing loss
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 |
|---|---|---|
| Silicone EarplugsSilicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first | Device | E |
| ControlStandard care in the neonatal intensive care unit | Other | C |
Primary outcome
Weight
Time frame: 34 weeks post-menstrual age
8 secondary outcomes
Length of stay in neonatal intensive care
Time frame: hospital discharge
Time on mechanical ventilator
Time frame: hospital discharge
Weight
Time frame: 18 - 22 months of age
Length
Time frame: 18 - 22 months of age
Frontal-occipital circumference
Time frame: 18 - 22 months of age
Bayley Mental Developmental Index
Time frame: 18 - 22 months of age
Bayley Psychomotor Developmental Index
Time frame: 18 - 22 months of age
ABR Hearing Screen
Time frame: hospital discharge
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 29 Nov 2007.
- Derived from this study: PubMed 19194455Abou Turk C, Williams AL, Lasky RE. A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care. J Perinatol. 2009 May;29(5):358-63. doi: 10.1038/jp.2008.236. Epub 2009 Feb 5.
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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.
Robert E Lasky, PhD principal investigator
University of Texas Medical School at Houston
Questions about this trial
What is this clinical trial studying?
A study testing Silicone Earplugs in people with Postnatal Growth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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 3 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 29 Nov 2007. 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?
Weight (time frame: 34 weeks post-menstrual 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 NCT00565357, 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 29 Nov 2007.