Preterm BirthGROWNDUPNCT01747603
The GROWNDUP Study of Late Preterm Births
A study testing Specialized LPTB clinic in people with Preterm Birth, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Specialized LPTB clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- May 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6
McMaster Children's Hospital & McMaster University
Hamilton, Ontario, L8S 4K1
About this study
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
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.
Read more
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.
Read the 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:
- An RCT that will study if a specialized LPTB clinic is effective in reducing short-term medical and developmental complications and hospital readmissions,
- Development of a sustainable long-term follow-up programme supported by evidence,
- Development of a database to track long-term complications, with the goal of identifying potential risk factors earlier in late preterm infants,
- Creation and dissemination of Evidence-Based Guidelines, research results for frontline health care providers (GPs, Midwives, etc.), community hospitals and Local Health Integration Networks,
- Creation and dissemination of Parent Educational Resources for discharge of LPTB infants.
- Conditions
- Preterm Birth
- Being tested
- Specialized LPTB clinic
- Keywords
- Late preterm infant, Complications, Hospital readmissions, Follow-up, Pilot study
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized LPTB clinicOther
50% of enrolled infants will be randomized to the specialized LPTB follow-up clinic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Specialized LPTB clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment Rate during first six months of pilot. Reported as the percentage of subjects recruited from those eligible to participate.
Measured: 14 months
Secondary outcomes (1)
Infant Weight Gain
Weight Gain reported in grams.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startMay 2013
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy Giglia, MD FRCP(C) MSc, Principal investigator, McMaster Children's Hospital & St. Joseph's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747603
- Sponsor's protocol ID
- 12-156
- Acronym
- GROWNDUP
- Status last verified
- Apr 2015
- First submitted
- 3 Dec 2012
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01747603
- Acronym / sponsor ID
- GROWNDUP / 12-156
- Conditions
- Preterm Birth
- Keywords
- Late preterm infant, Complications, Hospital readmissions, Follow-up, Pilot study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- An RCT that will study if a specialized LPTB clinic is effective in reducing short-term medical and developmental complications and hospital readmissions,
- Development of a sustainable long-term follow-up programme supported by evidence,
- Development of a database to track long-term complications, with the goal of identifying potential risk factors earlier in late preterm infants,
- Creation and dissemination of Evidence-Based Guidelines, research results for frontline health care providers (GPs, Midwives, etc.), community hospitals and Local Health Integration Networks,
- Creation and dissemination of Parent Educational Resources for discharge of LPTB infants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Specialized LPTB clinicAdditional 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. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized LPTB clinic50% of enrolled infants will be randomized to the specialized LPTB follow-up clinic. | Other | Specialized LPTB Clinic |
Primary outcome
Recruitment Rate
Time frame: 14 months
Recruitment Rate during first six months of pilot. Reported as the percentage of subjects recruited from those eligible to participate.
1 secondary outcome
Infant Weight Gain
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Giglia, MD FRCP(C) MSc principal investigator
McMaster Children's Hospital & St. Joseph's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized LPTB clinic in people with Preterm Birth, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.