Severity Index of Neonatal Septicemia Using Score for Neonatal Acute Physiology (SNAP) II (SNAP)

• ClinicalTrials.gov Identifier: NCT03746743
• Recruitment Status: Completed
• First Posted: November 20, 2018
• Last Update Posted: November 20, 2018
• Sponsor: Ahmed Mahmoud Ali Ali Youssef
• Information provided by (Responsible Party): Ahmed Mahmoud Ali Ali Youssef, Cairo University

Study Description

Brief Summary:

To determine the effect of Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia in the Neonatal Intensive Care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL.

Condition or disease	Intervention/treatment
Neonatal SEPSIS	Diagnostic Test: score for neonatal sepsis

Detailed Description:

This study will be conducted at the Neonatal intensive care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL.

Population of study & disease condition:

Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.

Inclusion criteria:

1. Type of patient: Neonates with septicemia.
2. Age of patient: From 0-28 Days.
3. Sex: males and females.

Exclusion criteria:

1. Neonates with proved inborn error of metabolism.
2. Neonates with multiple congenital anomalies.
3. Neonates with severe birth asphyxia (APGAR score <4 at 5 minutes).

Methodology in details:

We will have 2 groups, each of them 50 neonates with septicemia. One group of premature neonates (32-36 weeks), the other group of full term neonates (>37 weeks).

All included Patients will be subjected to the following:

1. Full history with emphasis of relevant data as follows:

   Date of birth, gestational age (AGA or SGA), gender, day of sepsis onset.

2. Clinical assessment:

   Full systems examination.

3. Diagnosis of sepsis:

   • By abnormal Total leucocytic count or I/T ratio or CRP with clinical Suggestion (poor feeding, hepatomegaly, apnea, tachypnea, lethargy, …).
   • Confirm diagnosis by blood culture.

   Sepsis will be considered severe if the neonate has sepsis plus one of the following: 1) cardiovascular organ dysfunction (hypotension or need for vasoactive drug) 2) 2 of the following (metabolic acidosis, increase lactic acid, oliguria, Prolonged capillary refill time) 3) Organ dysfunction (respiratory, renal, neurologic, hematologic).

4. SNAP II score:

   For all neonates included in the study and its data collection within 24 hours from onset of sepsis, in the form of:

   • Lowest mean blood pressure.
   • Worst ratio of pao2/fio2
   • Lowest temperature.
   • Lowest serum PH.
   • Occurrence of multiple seizures.
   • Urine output<1 ml/kg/hour.

5. Follow up:

   Follow up all neonates included in the study for 14 days: for morbidity and mortality.

6. Diagnosis of organ dysfunction:

Respiratory: by CXR and clinical examination. CVS: by blood pressure, capillary refill time, shock and need for inotropes. Renal: by urine output, kidney function tests. Hematology: by picture of DIC or pancytopenia. Neurology: by seizures, dilated fixed pupil.

Possible Risk:

None.

Primary outcomes:

Using Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia.

Secondary outcomes:

Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome.

Sample size:

100 Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 14 Days
• Official Title: Severity Index of Neonatal Septicemia of Cases Admitted at Neonatal Intensive Care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL Using Score for Neonatal Acute Physiology (SNAP) II
• Actual Study Start Date: September 1, 2017
• Actual Primary Completion Date: August 31, 2018
• Actual Study Completion Date: September 14, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Preterm neonates; Neonates born between 32 and 37 weeks gestation	Diagnostic Test: score for neonatal sepsis; score for neonatal sepsis to predict morbidity
Fullterm neonates; Neonates born at or after 37 weeks gestation	Diagnostic Test: score for neonatal sepsis; score for neonatal sepsis to predict morbidity

Outcome Measures

Primary Outcome Measures :

1. Using Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia. [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :

1. Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome. [ Time Frame: through study completion, an average of 1 year ]

Eligibility Criteria

• Ages Eligible for Study: up to 28 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.

Criteria

Inclusion Criteria:

1. Type of patient: Neonates with septicemia.
2. Age of patient: From 0-28 Days.
3. Sex: males and females.

Exclusion Criteria:

1. Neonates with proved inborn error of metabolism.
2. Neonates with multiple congenital anomalies.
3. Neonates with severe birth asphyxia (APGAR score <4 at 5 minutes).

Contacts and Locations

Locations

Egypt

Faculty Of medicine Cairo University

Giza, Egypt, 12613

Sponsors and Collaborators

Ahmed Mahmoud Ali Ali Youssef

Investigators

• Principal Investigator: Nermin R Mohamed, MD; Cairo University

More Information

Additional Information:

• Responsible Party: Ahmed Mahmoud Ali Ali Youssef, Doctor, Cairo University
• ClinicalTrials.gov Identifier: NCT03746743
• Other Study ID Numbers: SNAP II Score
• First Posted: November 20, 2018
• Last Update Posted: November 20, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neonatal Sepsis; Sepsis; Infections; Infant, Newborn, Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes