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The GROWNDUP Study of Late Preterm Births

NCT01747603 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-04-08

No results posted yet for this study

Summary

This pilot study will examine the feasibility of conducting a large randomized clinical trial (RCT) to examine the role of a novel, specialized follow-up clinic in preventing complications among late preterm infants (LPTB), born between 34 and 36 weeks gestational age. 1) Study Process: Success will be achieved if 80% of a target population of 100 subjects is met within the first 6 months of recruitment being initiated. 2) Study Resources: Success will be achieved if 80% of follow up appointments are scheduled in a timely manner and if specialized LPTB physicians in the intervention complete assessments 75% of the time in the allocated time frame and 3) Scientific: 95% data completeness on data collection forms will be identified as success

A specialized LPTB follow-up clinic is innovative as no studies have evaluated such a programme and standardized follow-up and guidelines for the care of LPTB infants after discharge from hospital do not exist. Until recently, the incorrect assumption has been that these infants are healthy and have limited risks compared to term infants.

The study's main question, in addition to assessing the feasibility of this pilot, is: "Do differences exist in short-tem clinical and developmental outcomes among LPTB infants enrolled in an RCT who are randomized to a specialized LPTB follow-up programme when compared to infants randomized to current pragmatic management?" A RCT will provide evidence for the development of guidelines for the follow-up of LPTB infants in the first 6 months of life to reduce complications, readmissions and developmental problems.

The results of this study can be generalized to tertiary care and community hospitals and the general population.

Conditions

Interventions

OTHER

Specialized LPTB clinic

50% of enrolled infants will be randomized to the specialized LPTB follow-up clinic.

Sponsors & Collaborators

Principal Investigators

  • Lucy Giglia, MD FRCP(C) MSc · McMaster Children's Hospital & St. Joseph's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Canada

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01747603 on ClinicalTrials.gov