CClinicalTrials.gg
Status unknownNCT05823064Updated Apr 21, 2023

Respiratory Morbidities and Outcome in Late Preterm in Neonatal ICU

An observational study in Respiratory Morbidities, sponsored by Assiut University. Status unknown. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
1 Day to 28 Days
Sex
All
01

Study 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 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.

02

Conditions studied

  • Respiratory Morbidities
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Sampling method
Non-probability sample

Study population

20 Neonates born between 34 and 36 weeks of gestation

Inclusion criteria

  • late preterm neonates admitted to the Neonatal intensive care unit (NICU) at Assiut University Children's Hospital for one year.

Exclusion criteria

Exclusion Criteria:

patients with congenital heart diseases and multiple congenital anomalies.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To assess the respiratory morbidities

    To assess the respiratory morbidities in late preterm infants in neonatal ICU of Assiut university children hospital .

    Time frame: base line

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05823064
Lead sponsor
Assiut University
Responsible party
Alaa Nady Sadik (principal investigator, Assiut University) — Principal investigator
First posted
Apr 21, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Apr 21, 2023

Study contacts

Alaa N Sadik
Contact
alaanady6000@gmail.com
01098459103
Nafisa H Refaat
principal investigator · Assiut University
Mohamed A Sayed
principal investigator · Assiut University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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