Respiratory MorbiditiesNCT05823064
Respiratory Morbidities and Outcome in Late Preterm in Neonatal ICU
An observational study of Respiratory Morbidities, run by Assiut University.
Trial summary
Aim of the work: To assess the respiratory morbidities \& outcomes in late preterm infants in the neonatal ICU of Assiut university children's Hospital. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Respiratory Morbidities
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Observational
- 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 28 days
- All sexes
- Child
Study population: 20 Neonates born between 34 and 36 weeks of gestation
Who may be able to join
- late preterm neonates admitted to the Neonatal intensive care unit (NICU) at Assiut University Children's Hospital for one year.
Who cannot join
- patients with congenital heart diseases and multiple congenital anomalies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Respiratory Morbidities and Outcome in Late Preterm in Neonatal ICU of Assiut University Children Hospital, One Year Study
Aim of the work:
To assess the respiratory morbidities \& outcomes in late preterm infants in the neonatal ICU of Assiut university children's Hospital.
Read the detailed description
In the world, Preterm birth rates continue to rise. Many reasons account for this increase, such as demographic changes, infertility treatments, increases in maternal age, more multiple gestations, increasing obesity rates, and maternal comorbid conditions.
To evaluate the occurrence and impact of a condition, a precise definition and its related outcomes are necessary. Thus, a general classification for selected gestational age categories has been reported. Preterm birth refers to all deliveries < 37-0/7 weeks; this classification includes very preterm (< 32-0/7 weeks), moderately preterm (32-0/7 to 33-6/7 weeks), and late preterm births (34-0/7 to 36-6/7 weeks). Term births refer to deliveries that occur from 37-0/7 to 42-0/7 weeks, and post-term births refer to any delivery occurring after 42-0/7 weeks.
Neonates born between 34 and 36 weeks of gestation (late preterm or near-term births) comprise 71% of all preterm births in the United States.
Late preterm neonates have significantly higher rates of morbidity and mortality relative to those born at term (37-42 weeks).
In addition to higher risks for serious health complications, the mortality rate for late preterm infants is 3-fold higher than that for term infants (7.7 vs 2.5 per 1000 live births).
Late preterm delivery (71% of all preterm births) increases the incidence of respiratory pathology as respiratory distress syndrome (RDS), Transient tachypnea of the newborn (TTN), pneumonia with chest x-ray verification, persistent apnea and bradycardia, pulmonary hypertension, pneumothorax, meconium aspiration, pulmonary hypoplasia,( respiratory failure ) and the need of ventilator support when compared to term delivery.
Late preterm newborns increase other risks for feeding difficulty, jaundice, hypoglycemia, temperature instability, apnea, and respiratory distress.
- Conditions
- Respiratory Morbidities
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the respiratory morbidities
To assess the respiratory morbidities in late preterm infants in neonatal ICU of Assiut university children hospital .
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MorbiditiesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Nady Sadik, Assiut University
- Investigators
- Nafisa H Refaat, Principal investigator, Assiut UniversityMohamed A Sayed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823064
- Sponsor's protocol ID
- Respiratory morbidities
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Morbidities and Outcome in Late Preterm in Neonatal ICU of Assiut University Children Hospital, One Year Study
- ClinicalTrials.gov ID
- NCT05823064
- Acronym / sponsor ID
- Respiratory morbidities
- Conditions
- Respiratory Morbidities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 21 Apr 2023 (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.
Aim of the work:
To assess the respiratory morbidities \& outcomes in late preterm infants in the neonatal ICU of Assiut university children's Hospital.
Detailed description
In the world, Preterm birth rates continue to rise. Many reasons account for this increase, such as demographic changes, infertility treatments, increases in maternal age, more multiple gestations, increasing obesity rates, and maternal comorbid conditions.
To evaluate the occurrence and impact of a condition, a precise definition and its related outcomes are necessary. Thus, a general classification for selected gestational age categories has been reported. Preterm birth refers to all deliveries < 37-0/7 weeks; this classification includes very preterm (< 32-0/7 weeks), moderately preterm (32-0/7 to 33-6/7 weeks), and late preterm births (34-0/7 to 36-6/7 weeks). Term births refer to deliveries that occur from 37-0/7 to 42-0/7 weeks, and post-term births refer to any delivery occurring after 42-0/7 weeks.
Neonates born between 34 and 36 weeks of gestation (late preterm or near-term births) comprise 71% of all preterm births in the United States.
Late preterm neonates have significantly higher rates of morbidity and mortality relative to those born at term (37-42 weeks).
In addition to higher risks for serious health complications, the mortality rate for late preterm infants is 3-fold higher than that for term infants (7.7 vs 2.5 per 1000 live births).
Late preterm delivery (71% of all preterm births) increases the incidence of respiratory pathology as respiratory distress syndrome (RDS), Transient tachypnea of the newborn (TTN), pneumonia with chest x-ray verification, persistent apnea and bradycardia, pulmonary hypertension, pneumothorax, meconium aspiration, pulmonary hypoplasia,( respiratory failure ) and the need of ventilator support when compared to term delivery.
Late preterm newborns increase other risks for feeding difficulty, jaundice, hypoglycemia, temperature instability, apnea, and respiratory distress.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- 20 Neonates born between 34 and 36 weeks of gestation
Key inclusion criteria (1 listed)
- late preterm neonates admitted to the Neonatal intensive care unit (NICU) at Assiut University Children's Hospital for one year.
Key exclusion criteria (1 listed)
- patients with congenital heart diseases and multiple congenital anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the respiratory morbidities
Time frame: base line
To assess the respiratory morbidities in late preterm infants in neonatal ICU of Assiut university children hospital .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- 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.
Nafisa H Refaat principal investigator
Assiut University
Mohamed A Sayed principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Morbidities, run by Assiut University.
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 1 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 21 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa N Sadik (01098459103, alaanady6000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the respiratory morbidities (time frame: base line). 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 21 Apr 2023.