Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609549497047 Date of Registration: 10/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nurse-Led Postoperative Care Bundle: Its Effect on Physiological Stability and Early Recovery Outcomes in Neonates Undergoing Tracheoesophageal Fistula Repair
Official scientific title Nurse-Led Postoperative Care Bundle: Its Effect on Physiological Stability and Early Recovery Outcomes in Neonates Undergoing Tracheoesophageal Fistula Repair
Brief summary describing the background and objectives of the trial Background: Neonates undergoing tracheoesophageal fistula (TEF) repair are at high risk of postoperative respiratory, nutritional, and physiological complications. Standardized nurse-led care bundles may improve the consistency and quality of postoperative care. Aim: This study aimed to evaluate the effect of a nurse-led postoperative care bundle on physiological stability and early recovery outcomes in neonates undergoing tracheoesophageal fistula repair. Methods: A quasi-experimental, non-randomized, pretest–posttest control group design was employed in the current study. Setting: The study was conducted in the Neonatal Intensive Care Units of the Specialized Pediatric Hospital among 80 NICU nurses and 60 neonates undergoing TEF repair and allocated to study and control groups. Three tools used in current study; Tool (I) Pre-designed Questionnaire Format. Tool (II): Postoperative care bundle checklist for neonates undergoing tracheoesophageal fistula repair and Tool (III): Neonatal Physiological Stability and Early Recovery Outcomes Assessment Sheet.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2026
Actual trial start date 01/03/2026
Anticipated date of last follow up 28/08/2026
Actual Last follow-up date 28/08/2026
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nurse Led Postoperative Care Bundle 6 sessions total (2 theoretical sessions of 30-45 mins + 4 practical sessions of 60 mins each) conducted over 4 months. 6 months (1 month assessment, 4 months implementation, 1 month evaluation). Implementation of a structured, evidence-based Nurse Led Postoperative Care Bundle focusing on airway management, positioning and anastomosis protection, hemodynamic monitoring, pain management, early enteral feeding, infection prevention, and complication monitoring. Group Breakdown & Sample Note: This group comprises 30 neonates undergoing TEF repair who receive postoperative care from a dedicated group of 40 NICU nurses trained on the care bundle protocols. Outcomes measure both nurse implementation performance and neonatal physiological stability and recovery. 30
Control Group Routine Postoperative Care Routine standard care provided according to the NICU hospital protocol without specific bundle training sessions. Standard postoperative period until hospital discharge Provision of routine, standard postoperative nursing care protocols currently practiced in the NICU for neonates undergoing TEF repair, without exposure to the structured care bundle training. Group Breakdown & Sample Note: This group comprises 30 neonates undergoing TEF repair who receive standard care from a separate group of 40 NICU nurses (routine practice). Outcomes measure both baseline nurse performance and neonatal physiological stability and recovery for comparison with the intervention group. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
neonates undergoing tracheoesophageal fistula repair who were admitted to the previously mentioned NICU and whose parents agreed to participate in the study. The exclusion criteria included neonates with other types of congenital anomalies or life-threatening conditions. Adult: 18 Year(s)-44 Year(s),New born: 0 Day-1 Month 1 Day(s) 28 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/07/2026 Scientific Research Ethics Committee Faculty of Nursing Benha University
Ethics Committee Address
Street address City Postal code Country
Fareed Nada Street Benha 13511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nurses' Knowledge Regarding Postoperative Care Assessment of nurses' knowledge level regarding tracheoesophageal fistula repair postoperative care using a pre designed questionnaire. Nurses' Clinical Practice Performance Assessment of nurses' adherence and competency in implementing the postoperative care bundle using an observational checklist (8 domains, 40 items). neonatal Physiological Stability Total physiological stability score evaluating cardiovascular, respiratory, thermoregulation, and fluid perfusion status (score 0 to 20). Neonatal Early Recovery Outcomes Evaluation of postoperative clinical recovery parameters including duration of mechanical ventilation, time to initiation of enteral feeding, time to full oral feeding, length of NICU stay, postoperative pain scores (using NIPS), and incidence of postoperative complications (e.g., sepsis, anastomotic leak). Measured at baseline pre intervention and 1 month post intervention for neonates monitored continuously throughout the postoperative NICU stay until discharge.
Secondary Outcome not applicable not applicable
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Specialized Pediatric Hospital Fareed Nada Street Benha 13511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nora Abd El Alim Ebrahim Fareed Nada Street Benha 13511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Nursing Benha University Farid Naddah Street Benha Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nora Abd El Alim Ebrahim noura.ibrahim@fnur.bu.edu.eg 01009530367 Farid Naddah Street
City Postal code Country Position/Affiliation
Benha Egypt Lecturer Benha Univesity
Role Name Email Phone Street address
Public Enquiries Nora Abd El Alim Ebrahim noura.ibrahim@fnur.bu.edu.eg 01009530367 Farid Naddah Street
City Postal code Country Position/Affiliation
Benha Egypt Lecturer Benha University
Role Name Email Phone Street address
Scientific Enquiries Nora Abd El Alim Ebrahim noura.ibrahim@fnur.bu.edu.eg 01009530367 Farid Naddah Street
City Postal code Country Position/Affiliation
Benha Egypt Lecturer Benha University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data (IPD) will not be shared or made publicly available to protect participant privacy and confidentiality. Informed Consent Form,Study Protocol Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/08/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/08/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 04/09/2026 The total participant number was updated to 60 to reflect the primary target population (neonates undergoing TEF repair) used in the statistical power and sample size calculation (G*Power). The study employs a nested design where 80 NICU nurses provide care to these 60 neonates. The numbers across Trial Basic Info and Intervention sections have now been unified to 60 to resolve the reviewer's comment. 80 60
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/09/2026 In response to the reviewer's comment regarding sample size alignment: The total sample size has been updated from 80 to 60 participants to match the primary target population (60 neonates) used for the statistical power calculation (G*Power) and primary outcome assessments. This study utilizes a nested design where 80 NICU nurses provide care to these 60 neonates (30 study neonates cared for by 40 study nurses; 30 control neonates cared for by 40 control nurses). The participant numbers across the Trial Basic Info and Intervention sections are now fully unified to 60. Experimental Group, Nurse Led Postoperative Care Bundle, 6 sessions total (2 theoretical sessions of 30-45 mins + 4 practical sessions of 60 mins each) conducted over 4 months., 6 months (1 month assessment, 4 months implementation, 1 month evaluation)., Implementation of a structured, evidence-based Nurse Led Postoperative Care Bundle focusing on airway management, positioning and anastomosis protection, hemodynamic monitoring, pain management, early enteral feeding, infection prevention, and complication monitoring. Group Breakdown & Sample Note: This group comprises 30 neonates undergoing TEF repair who receive postoperative care from a dedicated group of 40 NICU nurses trained on the care bundle protocols. Outcomes measure both nurse implementation performance and neonatal physiological stability and recovery., 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/09/2026 In response to the reviewer's comment regarding sample size alignment: The total sample size has been updated from 80 to 60 participants to match the primary target population (60 neonates) used for the statistical power calculation (G*Power) and primary outcome assessments. This study utilizes a nested design where 80 NICU nurses provide care to these 60 neonates (30 study neonates cared for by 40 study nurses; 30 control neonates cared for by 40 control nurses). The participant numbers across the Trial Basic Info and Intervention sections are now fully unified to 60. Control Group, Routine Postoperative Care, Routine standard care provided according to the NICU hospital protocol without specific bundle training sessions., Standard postoperative period until hospital discharge, Routine postoperative nursing care for neonates undergoing tracheoesophageal fistula repair, delivered by nurses who received standard hospital procedures without the standardized evidence-based care bundle training., 30, Active-Treatment of Control Group Control Group, Routine Postoperative Care, Routine standard care provided according to the NICU hospital protocol without specific bundle training sessions., Standard postoperative period until hospital discharge, Provision of routine, standard postoperative nursing care protocols currently practiced in the NICU for neonates undergoing TEF repair, without exposure to the structured care bundle training. Group Breakdown & Sample Note: This group comprises 30 neonates undergoing TEF repair who receive standard care from a separate group of 40 NICU nurses (routine practice). Outcomes measure both baseline nurse performance and neonatal physiological stability and recovery for comparison with the intervention group., 30, Active-Treatment of Control Group