The GROWNDUP Study of Late Preterm Births

NCT01747603 | Unknown

• 1 other identifier: 12-156
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm Birth

Keywords

Late preterm infant; Complications; Hospital readmissions; Follow-up; Pilot study

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

  Recruitment Rate during first six months of pilot. Reported as the percentage of subjects recruited from those eligible to participate.

  14 months

Secondary Outcomes (1)

• Infant Weight Gain

  14 months

Other Outcomes (1)

• Hospital Readmission

  14 months

Study Arms (2)

Current management of LPTB

NO INTERVENTION

The current pragmatic, but non-systematic, pattern of management of LPTB infants. Growth measurements, feeding histories/methods, illness history including emergent visits to clinicians, walk-in clinics and emergency departments and breast-feeding support clinics, and basic developmental milestones (as itemized in the Rourke Developmental screening tool) will be recorded by families and primary health care providers as itemized in the Memory Book at the assessments made at the discretion of the health care providers.

Specialized LPTB Clinic

EXPERIMENTAL

Additional 6 specialized LPTB follow-up clinic visits attended by pediatricians and neonatologists. Detailed findings from physical examination, feeding histories/methods, illness history including emergent visits to clinicians, walk-in clinics and emergency departments and breast-feeding support clinics, basic developmental milestones (as itemized in the Rourke Developmental screening tool) and physician recommendations will be recorded at each appointment. These will be compared to those obtained from families and primary health care providers as itemized in the Memory Book.

Other: Specialized LPTB clinic

Interventions

Specialized LPTB clinic OTHER

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

Specialized LPTB Clinic

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

St. Joseph's Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

McMaster Children's Hospital & McMaster University

Hamilton, Ontario, L8S 4K1, Canada

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 Officials

• Lucy Giglia, MD FRCP(C) MSc

  McMaster Children's Hospital & St. Joseph's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 11, 2012
• Study Start: May 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CA (2)