Transient Tachypnea of the NewbornPhase 1NCT05006235
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn (TTN)
A Phase 1 study testing Epinephrine Inhalation Solution, Salbutamol and Saline Inhalants in people with Transient Tachypnea of the Newborn, run by Ahmed Noaman.
Trial summary
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn: Randomized controlled trial to assess: Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- Transient Tachypnea of the Newborn
- What is being tested?
- Epinephrine Inhalation Solution, Salbutamol and Saline Inhalants
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2014to 31 Dec 2015
- Phase
- Phase 1
- 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 hour to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- babies with 35 weeks of gestation or more in the first 6 hours of life diagnosed with TTN according to the criteria of which are:
- Tachypnea (respiratory rate exceeding 60 breaths/ min) within 6 hours after birth
- Persistence of tachypnea for at least 12 hours
- Mild cyanosis, nasal flaring, or retractions.
- Chest radiograph indicating at least one of the following:
- Prominent central vascular markings
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- Widened interlobar fissures
- Symmetrical perihilar congestion
- Hyperaeration is evidenced by flattening and depression of the diaphragmatic domes.
Who cannot join
- Newborn infants with gestational age < 35 weeks
- Meconium aspiration
- Respiratory distress syndrome
- Pneumonia
- Congenital heart diseases including persistent pulmonary hypertension of the neworn (PPHN)
- Sepsis or suspected sepsis
Show all 10Show fewer
- Polycythemia
- Newborn infants with congenital malformations and chromosomal anomalies
- Newborn infants with ventilatory support.
- Newborn infants with arrhythmia
About this study
Official title: Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn: Randomized controlled trial to assess:
Read the detailed description
This is a randomized double-blind randomized controlled trial. It had been conducted at the Neonatal Intensive Care Unit (NICU) of Mansoura University Children's Hospital, Egypt Written informed consent had been taken from all parents whose infants were recruited in the study. The ethics committee of the faculty of medicine has approved the study.
- Conditions
- Transient Tachypnea of the Newborn
- Being tested
- Epinephrine Inhalation Solution, Salbutamol, Saline Inhalants
- Keywords
- Transient Tachypnea of the Newborn (TTN), epinephrine, salbutamol, respiratory distress, newborn
- Medical subject headings
- Transient Tachypnea of the Newborn, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine Inhalation SolutionDrug
SalbutamolDrug
Saline InhalantsDrug
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol Group | Active comparator | included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline Receives: Drug: Salbutamol |
| Epinephrine Group | Active comparator | included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline Receives: Drug: Epinephrine Inhalation Solution |
| Saline Group | Placebo comparator | include babies who had received nebulized 0.9% saline Receives: Drug: Saline Inhalants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of oxygen support & O2 concentration until Downes' score less than 4
Measured: through study completion, about 1 year
Secondary outcomes (3)
Length of hospital stay until Downes' score less than 4
Measured: through study completion, about 1 year
Type of respiratory support (oxygen delivery and oxygen concentration)
Measured: within 12 hours after intervention
Effect of intervention on blood sugar (mg/dl)
Measured: within 12 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Feb 2014
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Transient Tachypnea of the NewbornStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Noaman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Noaman, Mansoura University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006235
- Sponsor's protocol ID
- MansouraUCH0321
- Status last verified
- Aug 2021
- First submitted
- 21 Jul 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertrand P, Aranibar H, Castro E, Sanchez I. Efficacy of nebulized epinephrine versus salbutamol in hospitalized infants with bronchiolitis. Pediatr Pulmonol. 2001 Apr;31(4):284-8. doi: 10.1002/ppul.1040.
PubMed 11288210Clark RH. The epidemiology of respiratory failure in neonates born at an estimated gestational age of 34 weeks or more. J Perinatol. 2005 Apr;25(4):251-7. doi: 10.1038/sj.jp.7211242.
PubMed 15605071Rawlings JS, Smith FR. Transient tachypnea of the newborn. An analysis of neonatal and obstetric risk factors. Am J Dis Child. 1984 Sep;138(9):869-71. doi: 10.1001/archpedi.1984.02140470067022.
PubMed 6540983Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.
PubMed 23736015Vollsaeter M, Roksund OD, Eide GE, Markestad T, Halvorsen T. Lung function after preterm birth: development from mid-childhood to adulthood. Thorax. 2013 Aug;68(8):767-76. doi: 10.1136/thoraxjnl-2012-202980. Epub 2013 Jun 7.
PubMed 23749815Yurdakok M. Transient tachypnea of the newborn: what is new? J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:24-6. doi: 10.3109/14767058.2010.507971.
PubMed 20807157
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn
- ClinicalTrials.gov ID
- NCT05006235
- Acronym / sponsor ID
- MansouraUCH0321
- Conditions
- Transient Tachypnea of the Newborn
- Keywords
- Transient Tachypnea of the Newborn (TTN), epinephrine, salbutamol, respiratory distress, newborn
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Ahmed NoamanUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 16 Aug 2021 (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.
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn: Randomized controlled trial to assess:
Detailed description
This is a randomized double-blind randomized controlled trial. It had been conducted at the Neonatal Intensive Care Unit (NICU) of Mansoura University Children's Hospital, Egypt Written informed consent had been taken from all parents whose infants were recruited in the study. The ethics committee of the faculty of medicine has approved the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Salbutamol Group | Active comparator | Drug: Salbutamolincluded babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline |
| Epinephrine Group | Active comparator | Drug: Epinephrine Inhalation Solutionincluded babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline |
| Saline Group | Placebo comparator | Drug: Saline Inhalantsinclude babies who had received nebulized 0.9% saline |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- babies with 35 weeks of gestation or more in the first 6 hours of life diagnosed with TTN according to the criteria of which are:
- Prominent central vascular markings
- Widened interlobar fissures
- Symmetrical perihilar congestion
- Hyperaeration is evidenced by flattening and depression of the diaphragmatic domes.
Key exclusion criteria (10 listed)
- Newborn infants with gestational age < 35 weeks
- Meconium aspiration
- Respiratory distress syndrome
- Pneumonia
- Congenital heart diseases including persistent pulmonary hypertension of the neworn (PPHN)
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 |
|---|---|---|
| Epinephrine Inhalation Solution | Drug | Epinephrine Group |
| Salbutamol | Drug | Salbutamol Group |
| Saline Inhalants | Drug | Saline Group |
Primary outcome
Duration of oxygen support & O2 concentration until Downes' score less than 4
Time frame: through study completion, about 1 year
3 secondary outcomes
Length of hospital stay until Downes' score less than 4
Time frame: through study completion, about 1 year
Type of respiratory support (oxygen delivery and oxygen concentration)
Time frame: within 12 hours after intervention
Effect of intervention on blood sugar (mg/dl)
Time frame: within 12 hours after intervention
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 Aug 2021.
- Background: PubMed 11288210Bertrand P, Aranibar H, Castro E, Sanchez I. Efficacy of nebulized epinephrine versus salbutamol in hospitalized infants with bronchiolitis. Pediatr Pulmonol. 2001 Apr;31(4):284-8. doi: 10.1002/ppul.1040.
- Background: PubMed 15605071Clark RH. The epidemiology of respiratory failure in neonates born at an estimated gestational age of 34 weeks or more. J Perinatol. 2005 Apr;25(4):251-7. doi: 10.1038/sj.jp.7211242.
- Background: PubMed 6540983Rawlings JS, Smith FR. Transient tachypnea of the newborn. An analysis of neonatal and obstetric risk factors. Am J Dis Child. 1984 Sep;138(9):869-71. doi: 10.1001/archpedi.1984.02140470067022.
- Background: PubMed 23736015Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.
- Background: PubMed 23749815Vollsaeter M, Roksund OD, Eide GE, Markestad T, Halvorsen T. Lung function after preterm birth: development from mid-childhood to adulthood. Thorax. 2013 Aug;68(8):767-76. doi: 10.1136/thoraxjnl-2012-202980. Epub 2013 Jun 7.
- Background: PubMed 20807157Yurdakok M. Transient tachypnea of the newborn: what is new? J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:24-6. doi: 10.3109/14767058.2010.507971.
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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 1 study testing Epinephrine Inhalation Solution, Salbutamol and Saline Inhalants in people with Transient Tachypnea of the Newborn, run by Ahmed Noaman.
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 9 inclusion and 10 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 Aug 2021. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Duration of oxygen support & O2 concentration until Downes' score less than 4 (time frame: through study completion, about 1 year). 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 NCT05006235, which also lists 6 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 16 Aug 2021.