Hyaline Membrane DiseasePhase 4NCT03366584
The Effect of β-Carotene, Vitamin D3 and Zinc on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates
A Phase 4 study testing Beta carotene, Vitamin D3 and Zinc in people with Hyaline Membrane Disease and Necrotizing Enterocolitis of Newborn, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Hyaline membrane disease, now commonly called respiratory distress syndrome (RDS), and feeding intolerance, which can lead to necrotizing enterocolitis (NEC), are two key morbidities found in premature neonates which resulted in high mortality rate in Indonesia. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyaline Membrane Disease, Necrotizing Enterocolitis of Newborn
- What is being tested?
- Beta carotene, Vitamin D3 and Zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- Jan 2017to Jun 2019
- Phase
- Phase 4
- 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 17 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women who has preterm birth in 28-34 weeks gestational age
Who cannot join
- Multiple pregnancy
- Drug allergy
- Fetal congenital malformation
- Maternal gestational diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Yuyun Lisnawati contact
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo General Hospital
Jakarta, DKI Jakarta, 12440
Yuyun Lisnawati, Consultant, +628161841987, yulisna.er@gmail.com
About this study
Official title: The Effect of Co-administered β-Carotene, Vitamin D3, Zinc and Antenatal Steroid Therapy on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates
Hyaline membrane disease, now commonly called respiratory distress syndrome (RDS), and feeding intolerance, which can lead to necrotizing enterocolitis (NEC), are two key morbidities found in premature neonates which resulted in high mortality rate in Indonesia. Cochrane meta-analysis proved that antenatal steroid therapy can reduce the morbidity and mortality rate of premature neonates. But there is still different outcomes and severity of disease in preterm newborn receiving the same dose of antenatal steroid therapy. This raises questions whether there are other factors influencing the development and maturity of lung and gut in preterm newborn, aside from steroid therapy. Vitamin A, D and zinc are already known for their function in fetal lung and gut development. To our best of knowledge, no study has evaluated the effect of these vitamins levels on HMD and feeding intolerance in premature neonates. Therefore, the aim of this study want to evaluate the effect of antenatal steroid therapy versus co-administered β-carotene, vitamin D3, zinc and antenatal steroid therapy on the presence and severity of HMD and feeding intolerance in premature neonates.
Read the detailed description
This study is a randomized controlled trial and held in Cipto Mangunkusumo Hospital.
Pregnant women 28-34 weeks of gestational age, who fulfill the inclusion criteria, divide into two groups. Subjects from both groups receive the hospital protocol of preterm birth, 4 doses of 6 mg of dexamethasone, intravenous 12 hours apart to support lung maturation. Subjects in intervention group receive oral single-dose beta-carotene 25,000 IU, oral single-dose vitamin D3 50,000 IU and oral zinc 50 mg/day for 3 days. The maternal dan cord blood sample are obtained for zinc, vitamin A and 25(OH)D levels before and after intervention. After the premature neonates was born, observation will be done for maximum period of 4 weeks. The presence and severity of HMD and feeding intolerance or NEC will be recorded. Neonates showing any signs of HMD and/or abdominal distension will need to undergo additional chest/abdominal x-ray procedures.
- Being tested
- Beta carotene, Vitamin D3, Zinc, Dexamethasone
- Medical subject headings
- Hyaline Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta caroteneDietary supplement
Beta carotene 25,000 IU
Vitamin D3Dietary supplement
Also called Cholecalciferol
Vitamin D3 50,000 IU
ZincDietary supplement
Also called Zinc picolinate
Zinc 50 mg
DexamethasoneDrug
Dexamethasone 6 mg
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | * beta carotene 25,000 IU
* vitamin D3 50,000 IU
* zinc 50 mg
* dexamethasone 6 mg Receives: Dietary Supplement: Beta carotene; Dietary Supplement: Vitamin D3; Dietary Supplement: Zinc; Drug: Dexamethasone |
| Control | Active comparator | dexamethasone 6 mg Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyaline membrane disease
The presence and severity of RDS (HMD) will be noted, according to chest X-ray result
Measured: 1,5 years
Secondary outcomes (1)
Feeding Intolerance
The presence and severity of necrotican enterocolitis will be noted, according to abdominal x-ray result
Measured: 1,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaline Membrane DiseaseStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research will be held in Cipto Mangunkusumo General Hospital. Each participant of each group will be given dexamethasone 2x6 mg intravenous for 2 days which aims to support lung maturation followed by planned delivery within 1 week due to indication of maternal or fetal. The maternal dan cord blood sample are obtained for zinc, vitamin A and 25(OH)D levels examinations. Randomly, subjects will be divided into 2 groups which are group who is given the oral beta-carotene 25,000 IU, oral vitamin D3 50,000 IU and oral zinc 50 mg/day for 3 days, and group who is not given the intervention. After the premature neonates was born, observation will be done for maximum period of 4 weeks. The presence and severity of HMD and feeding intolerance or NEC will be recorded.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuyun Lisnawati, Universitas Indonesia
- Investigators
- Yuyun Lisnawati, Study chair, Persahabatan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366584
- Sponsor's protocol ID
- 190/2016
- Status last verified
- Aug 2018
- First submitted
- 3 Dec 2017
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research findings will be disseminated via publication of results
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Co-administered β-Carotene, Vitamin D3, Zinc and Antenatal Steroid Therapy on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates
- ClinicalTrials.gov ID
- NCT03366584
- Acronym / sponsor ID
- 190/2016
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 8 Dec 2017 (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.
Hyaline membrane disease, now commonly called respiratory distress syndrome (RDS), and feeding intolerance, which can lead to necrotizing enterocolitis (NEC), are two key morbidities found in premature neonates which resulted in high mortality rate in Indonesia. Cochrane meta-analysis proved that antenatal steroid therapy can reduce the morbidity and mortality rate of premature neonates. But there is still different outcomes and severity of disease in preterm newborn receiving the same dose of antenatal steroid therapy. This raises questions whether there are other factors influencing the development and maturity of lung and gut in preterm newborn, aside from steroid therapy. Vitamin A, D and zinc are already known for their function in fetal lung and gut development. To our best of knowledge, no study has evaluated the effect of these vitamins levels on HMD and feeding intolerance in premature neonates. Therefore, the aim of this study want to evaluate the effect of antenatal steroid therapy versus co-administered β-carotene, vitamin D3, zinc and antenatal steroid therapy on the presence and severity of HMD and feeding intolerance in premature neonates.
Detailed description
This study is a randomized controlled trial and held in Cipto Mangunkusumo Hospital.
Pregnant women 28-34 weeks of gestational age, who fulfill the inclusion criteria, divide into two groups. Subjects from both groups receive the hospital protocol of preterm birth, 4 doses of 6 mg of dexamethasone, intravenous 12 hours apart to support lung maturation. Subjects in intervention group receive oral single-dose beta-carotene 25,000 IU, oral single-dose vitamin D3 50,000 IU and oral zinc 50 mg/day for 3 days. The maternal dan cord blood sample are obtained for zinc, vitamin A and 25(OH)D levels before and after intervention. After the premature neonates was born, observation will be done for maximum period of 4 weeks. The presence and severity of HMD and feeding intolerance or NEC will be recorded. Neonates showing any signs of HMD and/or abdominal distension will need to undergo additional chest/abdominal x-ray procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The research will be held in Cipto Mangunkusumo General Hospital. Each participant of each group will be given dexamethasone 2x6 mg intravenous for 2 days which aims to support lung maturation followed by planned delivery within 1 week due to indication of maternal or fetal. The maternal dan cord blood sample are obtained for zinc, vitamin A and 25(OH)D levels examinations. Randomly, subjects will be divided into 2 groups which are group who is given the oral beta-carotene 25,000 IU, oral vitamin D3 50,000 IU and oral zinc 50 mg/day for 3 days, and group who is not given the intervention. After the premature neonates was born, observation will be done for maximum period of 4 weeks. The presence and severity of HMD and feeding intolerance or NEC will be recorded.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Beta carotene, Dietary Supplement: Vitamin D3, Dietary Supplement: Zinc, Drug: Dexamethasone* beta carotene 25,000 IU * vitamin D3 50,000 IU * zinc 50 mg * dexamethasone 6 mg |
| Control | Active comparator | Drug: Dexamethasonedexamethasone 6 mg |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women who has preterm birth in 28-34 weeks gestational age
Key exclusion criteria (4 listed)
- Multiple pregnancy
- Drug allergy
- Fetal congenital malformation
- Maternal gestational diabetes mellitus
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 |
|---|---|---|
| Beta caroteneBeta carotene 25,000 IU | Dietary supplement | Intervention |
| Vitamin D3Also: CholecalciferolVitamin D3 50,000 IU | Dietary supplement | Intervention |
| ZincAlso: Zinc picolinateZinc 50 mg | Dietary supplement | Intervention |
| DexamethasoneDexamethasone 6 mg | Drug | Control, Intervention |
Primary outcome
Hyaline membrane disease
Time frame: 1,5 years
The presence and severity of RDS (HMD) will be noted, according to chest X-ray result
1 secondary outcome
Feeding Intolerance
Time frame: 1,5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: Undecided. The research findings will be disseminated via publication of results
Related trials for Hyaline Membrane Disease
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Not yet recruitingObservational study
Effect of Automated Oxygen Control on Early-childhood Lung Mechanics
Prematurity, Respiratory Distress Neonatal
Not yet recruiting
Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
Respiratory Distress Syndrome (RDS), Newborn
RecruitingObservational study
Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study
Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal)
Not yet recruiting
The NEU - CAP Trial
Infant, Premature, Diseases, Birth, Preterm
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.
Yuyun Lisnawati contact
Yuyun Lisnawati study chair
Persahabatan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta carotene, Vitamin D3 and Zinc in people with Hyaline Membrane Disease and Necrotizing Enterocolitis of Newborn, run by Universitas Indonesia at 1 site in Indonesia.
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 4 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 13 Aug 2018. 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 Indonesia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yuyun Lisnawati (yulisna.er@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyaline membrane disease (time frame: 1,5 years). 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 13 Aug 2018.