Improving SCBU Care for Preterm Babies

NCT03512093 | Completed

• 1 other identifier: HCR17005
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Preterm Birth

Keywords

Preterm Infant

Outcome Measures

Primary Outcomes (3)

• 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

• The neonatal prematurity-related morbidity rates.

  (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.

  1 year

• The time lapse between birth and full enteral feeding expressed as mean (SD) days to reach full enteral feeding.

  1 year

Secondary Outcomes (4)

• 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

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

  1 year

• The mean (SD) neurodevelopment score at 6 and 12 month of life of neonates born < 34+0 weeks of gestation.

  1 year

• 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

Study Arms (3)

Retrospective chart review

Other: Retrospective chart review

Focus Group Discussion (FGD) of the medical staff

Other: Focus Group Discussion (FGD) of the medical staff

Interviews of mothers

Other: Interviews of mothers

Interventions

Retrospective chart review OTHER

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.

Retrospective chart review

Focus Group Discussion (FGD) of the medical staff OTHER

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.

Focus Group Discussion (FGD) of the medical staff

Interviews of mothers OTHER

Interviews of mothers who delivered preterm neonates (\< 37+0 weeks of gestation) to understand the challenges they faced while caring for their child.

Interviews of mothers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seeking care to SMRU facilities belong to several distinct ethnic groups present along the Thailand-Myanmar border, mostly from Burman and Karen ethnicity, but also from Mon, Kachin, Shan or Rakhine ethnic background. Medical staff caring for those patients are from the same mixed of ethnic background. Part A: All neonates born prematurely (\< 37+0 weeks of gestation) in one of the SMRU clinics between January 2008 and December 2017 and for whom a medical record was created between its birth and its first birthday Part B: Medical staff directly involved with preterm care Part C: Mothers who have delivered a preterm neonate (\< 37+0 weeks of estation) in one of the SMRU clinics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Shoklo Malaria Research Unit: collaborator

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: April 30, 2018
• Study Start: May 1, 2018
• Primary Completion: March 16, 2021
• Study Completion: March 31, 2021
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TH (1)