PretermBabies: Improving SCBU Care for Preterm Babies

• Sponsor: University of Oxford (Other)
• Overall Status: Completed
• CT.gov ID: NCT03512093
• Collaborator: Shoklo Malaria Research Unit (Other)
• Enrollment: 36
• Location: 1
• Actual Duration (Months): 35
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Since 2008, preterm neonates are taking care of in a Special Baby Care Unit (SCBU). Those born less than 34 weeks of gestation are followed-up monthly for one year for monitoring their hematocrit level, growth and development.

Medical chart reviews are useful to evaluate the burden of diseases, characterize care treatment patterns and clinical outcomes by patients' subgroups; ultimately it can help identifying gaps in care pathways thus improving quality of care and ultimately reducing mortality. Medical records of all preterm neonates hospitalized in the SCBU including those followed up during their first year of life are computerized.

The investigators propose to review the clinical charts of the preterm neonates in regards to four main points of care a) feeding, b) infections including early onset of neonatal sepsis, necrotizing enterocolitis and umbilical cord infection, c) body temperature control and d) respiratory distress.

This medical charts review will be complemented by i) focus group discussions (FGD) with the medical staff working in the SCBU on the benefits and difficulties in using the existing guidelines for preterm care and by ii) interviews with mothers who delivered a preterm neonate on their experience in caring for their child and the challenges they faced.

While performing the retrospective part of the project and after discussing the preliminary findings from the medical staff perception of the existing guidelines, the investigators will evaluate the feasibility to implement some additional recommendations to improve preterm birth outcomes based on recent literature and new protocols for resource-limited settings.

Condition or Disease	Intervention/Treatment	Phase
Preterm Infant; Preterm Birth	Other: Retrospective chart review; Other: Focus Group Discussion (FGD) of the medical staff; Other: Interviews of mothers

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Born Too Soon in a Resource-limited Setting on the Thailand-Myanmar Border: Can we Improve Care in a Special Care Baby Unit?
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Mar 16, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Retrospective chart review	Other: Retrospective chart review; A retrospective chart review of preterm neonates born in one of the birthing SMRU unit between January 2008 and December 2017 and for whom a medical chart is available. In addition we propose to analyze the growth trajectory, the prevalence of anemia (Hct < 33%) and the level of neurodevelopment achieved in the first year of life reported in the clinical charts of preterm neonates born < 34+0 weeks of gestation.
Focus Group Discussion (FGD) of the medical staff	Other: Focus Group Discussion (FGD) of the medical staff; Focus Group Discussion (FGD) of the medical staff working in the SCBU firstly on the benefits and difficulties in using existing guidelines for preterm care and secondly on the feasibility and acceptability of changes in the guidelines 3-6 months after their implementation.
Interviews of mothers	Other: Interviews of mothers; Interviews of mothers who delivered preterm neonates (< 37+0 weeks of gestation) to understand the challenges they faced while caring for their child.

Outcome Measures

Primary Outcome Measures

1. The neonatal mortality rate of preterm neonates (< 37+ weeks of gestation) expressed in number of newborns dying at less than 28 days of age per 1000 livebirths. [1 year]

2. The neonatal prematurity-related morbidity rates. [1 year]

   (i.e. necrotizing enterocolitis; sepsis; hypothermia; apnoea of prematurity; respiratory distress syndrome; gastric reflux) expressed as the number of specific-morbidity per number of preterm newborn aged less than 28 days and presented as percentage.

3. The time lapse between birth and full enteral feeding expressed as mean (SD) days to reach full enteral feeding. [1 year]

Secondary Outcome Measures

1. The growth trajectory changes during the first year of life of neonates born < 34+0 weeks of gestation expressed as mean (SD) monthly weight/height gain and mean z-scores at end of follow-up. [1 year]

2. The proportion of anaemia (haematocrit < 33%) during the first year of life of neonates born < 34+0 weeks of gestation. [1 year]

3. The mean (SD) neurodevelopment score at 6 and 12 month of life of neonates born < 34+0 weeks of gestation. [1 year]

4. Medical staff and mothers' perception of the difficulties and challenges of caring for preterm neonates analysed by themes and performed using NVivo solfware package. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Part A: Neonatal medical record for preterm neonates (< 37+0 weeks of gestation) in one of the SMRU clinics between January 2008 and December 2017

• Part B: Male or female medical staff (Medics, midwives & nurses) aged 18 years and above, who have been working for SMRU since the introduction of the Special Care Baby Unit (2008-2011) or after its establishment (2012-2017) and have actively cared for preterm newborns. Medical staff (Medics, midwives & nurses) who have provided written informed consent and willing to participate to a Focus Group Discussion

• Part C: Mothers, aged 18 years and above, who have had a preterm newborn (< 37+0 weeks of gestation) admitted in SMRU clinics.

Multigravida or primigravid, presently in the SCBU or already discharged home who willing to discuss the broad topics include caring for the preterm newborn at home. Any mothers will be approached so that responses might provide a comprehensive overview of mothers concerns.

Mothers who have provided written informed consent and willing to participate to an interview

Exclusion Criteria:

• Parts A: Neonatal medical record of neonates < 37+0 weeks of gestation receiving palliative care only.

Neonatal medical record of neonates < 37+0 weeks of gestation born and hospitalized in tertiary hospital.

Neonatal medical record of neonates < 37+0 weeks of gestation born at home and not hospitalized in SMRU clinics during the neonatal period.

Neonatal medical record of neonates < 37+0 weeks of gestation born in SMRU clinics but transferred in tertiary hospital for further neonatal care.

Neonatal medical record of neonates born term (37+0 weeks or more)

• Part B: Medical staff who has never been directly involved in caring for preterm neonates.

• Part C: Mothers aged less than 18 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shoklo Malaria Research Unit	Mae Sot	Tak	Thailand	63110

Sponsors and Collaborators

• University of Oxford
• Shoklo Malaria Research Unit

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT03512093
• Other Study ID Numbers: HCR 17005
• First Posted: Apr 30, 2018
• Last Update Posted: Jun 21, 2021
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Oxford: Preterm Infant
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Jun 21, 2021