Very Low Birth Weight BabyDSCNCT02817022
Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
A study testing developmentally supportive care in people with Very Low Birth Weight Baby, run by Lady Hardinge Medical College at 2 sites in India.
Trial summary
Enrolled neonates will be provided routine supportive care as per existing neonatal intensive care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). Read more about this study
- Who is it for?
- Ages 1 day to 37 weeks
- Conditions the study is for
- Very Low Birth Weight Baby
- What is being tested?
- developmentally supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesIndia
- Study dates
- Jan 2016to Jun 2017
- 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 1 day to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All stable preterm very low birth weight babies not on invasive mechanical ventilation
- Hemodynamically stable
- Parental consent
Who cannot join
- Babies with major congenital anomalies
- Asphyxia (Apgar score <3 at 5mins).
- Acute bilirubin encephalopathy
- Hypoglycemia at enrollment
- Clinical Chorioamnionitis(fever > 100.4 ◦ f , uterine fundal tenderness, maternal tachycardia (>100/min), fetal tachycardia (>160/min) and purulent or foul amniotic fluid )
- History of birth trauma
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
Lady Hardinge Medical College,New Delhi
Delhi
Vikram Datta, MD, 919350801230, vikramdatta71@yahoo.com
Vikram Datta, MD
- Recruiting
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, 110001
Vikram Datta, MD,DNB, +919899114104, drvikramdatta@gmail.com
About this study
Official title: Evaluation of the Effect of Application of Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
Enrolled neonates will be provided routine supportive care as per existing neonatal intensive care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC).
Read the detailed description
Enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B. Both the groups will receive appropriate management for their morbidities as per existing NICU protocols. Both the groups will be followed up till 37 weeks of gestation where in their neurobehavioral assessment will be performed using Neurobehavioural assessment of preterm infants score.
In both the groups all the baseline data regarding antenatal factors will be recorded in a predesigned proforma such as age, gravid, Gestational age, Chorioamnionitis, Prenatal steroids, Multiple pregnancy, maternal comorbidities (preeclampsia, gestational diabetes mellitus), mode of delivery etc.
- Conditions
- Very Low Birth Weight Baby
- Being tested
- developmentally supportive care
- Keywords
- Developmentally Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
developmentally supportive careOther
DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment
| Study group | Role | What they receive |
|---|---|---|
| developmentally supportive care | Other | enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care(DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B Receives: Other: developmentally supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavioral outcome Of the Preterm Very low birth weight babies
Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age.
Measured: 18 months
Secondary outcomes (2)
Time to achieve full feeds @150ml/kg
Time to achieve full feed @150 ml/kg/day will be measured in days.
Measured: 18 months
Length of hospital stay
will be measured in days
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight BabyStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DR. VIKRAM DATTA, Lady Hardinge Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817022
- Sponsor's protocol ID
- Developmental supportive care
- Acronym
- DSC
- Status last verified
- Jun 2016
- First submitted
- 29 Apr 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Application of Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
- ClinicalTrials.gov ID
- NCT02817022
- Acronym / sponsor ID
- DSC / Developmental supportive care
- Conditions
- Very Low Birth Weight Baby
- Keywords
- Developmentally Supportive Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Jun 2016 (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.
Enrolled neonates will be provided routine supportive care as per existing neonatal intensive care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC).
Detailed description
Enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B. Both the groups will receive appropriate management for their morbidities as per existing NICU protocols. Both the groups will be followed up till 37 weeks of gestation where in their neurobehavioral assessment will be performed using Neurobehavioural assessment of preterm infants score.
In both the groups all the baseline data regarding antenatal factors will be recorded in a predesigned proforma such as age, gravid, Gestational age, Chorioamnionitis, Prenatal steroids, Multiple pregnancy, maternal comorbidities (preeclampsia, gestational diabetes mellitus), mode of delivery etc.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| developmentally supportive care | Other | Other: developmentally supportive careenrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care(DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B |
Who may qualify
- Ages
- 1 day to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All stable preterm very low birth weight babies not on invasive mechanical ventilation
- Hemodynamically stable
- Parental consent
Key exclusion criteria (6 listed)
- Babies with major congenital anomalies
- Asphyxia (Apgar score <3 at 5mins).
- Acute bilirubin encephalopathy
- Hypoglycemia at enrollment
- Clinical Chorioamnionitis(fever > 100.4 ◦ f , uterine fundal tenderness, maternal tachycardia (>100/min), fetal tachycardia (>160/min) and purulent or foul amniotic fluid )
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 |
|---|---|---|
| developmentally supportive careDSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment | Other | developmentally supportive care |
Primary outcome
Neurobehavioral outcome Of the Preterm Very low birth weight babies
Time frame: 18 months
Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age.
2 secondary outcomes
Time to achieve full feeds @150ml/kg
Time frame: 18 months
Length of hospital stay
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing developmentally supportive care in people with Very Low Birth Weight Baby, run by Lady Hardinge Medical College at 2 sites in India.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VIKRAM DATTA, MD,DNB (91-1123344151 ext. 329, drvikramdatta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral outcome Of the Preterm Very low birth weight babies (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2016.