Clinical trial NCT01747603: The GROWNDUP Study of Late Preterm Births
Official title: The GROWNDUP Study: Pilot to Assess the Feasibility of an RCT for Promoting Growth, Nutrition and Development Through a Specialized Late Preterm Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Keywords: Late preterm infant
Complications
Hospital readmissions
Follow-up
Pilot study
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 100
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Late preterm births comprise 70-75% of all preterm births in Ontario and 5.8% of all births in the province. These infants are at significant risk for complications but no guidelines or follow-up programmes exist for decreasing the short and long-term complications associated with LPTB. This project will lay the groundwork for gathering the research evidence to support:

1. An RCT that will study if a specialized LPTB clinic is effective in reducing short-term medical and developmental complications and hospital readmissions,
2. Development of a sustainable long-term follow-up programme supported by evidence,
3. Development of a database to track long-term complications, with the goal of identifying potential risk factors earlier in late preterm infants,
4. Creation and dissemination of Evidence-Based Guidelines, research results for frontline health care providers (GPs, Midwives, etc.), community hospitals and Local Health Integration Networks,
5. Creation and dissemination of Parent Educational Resources for discharge of LPTB infants.

Eligibility criteria: Inclusion Criteria:

- singleton or twins born at 34 and 0 days to 36 weeks and 6 days gestational age. Infants admitted to the Level 2 Nursery or newborn nursery at McMaster Children's Hospital or St. Joseph's Healthcare Hamilton or Level 3 Nursery (NICU) at McMaster Children's Hospital will be included.

Exclusion Criteria:

* triplets and infants with major cardiac anomalies, metabolic disorders, significant gastrointestinal anomalies, intrauterine growth restriction, potential genetic syndromes, neurologic anomalies or severe sepsis/meningitis and LPTB requiring mechanical ventilation (post-delivery room resuscitation with prolonged CPAP or intubation) will be excluded.
* mothers who have a history of substance use at any time during pregnancy or alcohol use after confirmation of pregnancy
* participants must be able to understand English and speak English as this pilot does not currently have the financial support to sponsor interpreters.

Primary outcomes:
measure: Recruitment Rate
timeFrame: 14 months
Secondary outcomes:
measure: Infant Weight Gain
timeFrame: 14 months
Other outcomes:
measure: Hospital Readmission
timeFrame: 14 months
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Children's Hospital & McMaster University
state: Ontario
Study officials:
affiliation: McMaster Children's Hospital & St. Joseph's Hospital
name: Lucy Giglia, MD FRCP(C) MSc
role: PRINCIPAL_INVESTIGATOR
References: