Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05618769 |
| Other study ID # |
2021-117 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 18, 2022 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
September 2022 |
| Source |
Franciscus Gasthuis |
| Contact |
Kishan Tsang, MD |
| Phone |
+31(0)683278272 |
| Email |
k.tsang[@]franciscus.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Approximately 8% of all births occur between 30-36 weeks of gestation ('moderate-late'
prematurity). Respiratory tract infections (RTI) and wheezing illnesses disproportionally
affect preterm infants resulting in a 1.5-2 fold higher hospitalisation rate during the first
years of life compared to term born children. Besides prematurity, several other postnatal
modifiable influencing factors are associated with increased risk of respiratory morbidity
and impaired pulmonary development. These factors include RTI, rapid weight gain, air
pollution, tobacco smoke exposition, vitamin D deficiency, maternal stress and antibiotic
usage. The investigators hypothesize that a follow-up program aiming at prevention of
modifiable influencing factors can reduce respiratory morbidity in moderate and late
prematurity. Objectives: To reduce respiratory disease burden in moderate-late preterm
infants in the first 18 months of life
Description:
Background of the study:
Approximately 8% of all births occur between 30-36 weeks of gestation (moderate-late
prematurity). Respiratory tract infections (RTI) and wheezing illnesses disproportionally
affect preterms, resulting in a 1.5-2 fold higher hospitalization rate during the first years
of life compared to term-born children. Besides prematurity, several other modifiable
influencing factors are associated with increased risk of respiratory morbidity and impaired
pulmonary development. These factors include rapid weight gain and obesity at an early age,
tobacco smoke exposure, air pollution, microbiome composition, and recurrent RTI.
To promote optimal lung health and development in moderate-late preterm infants, increased
respiratory health surveillance and protection against RTI in early life might be crucial.
Previous research has shown that the introduction of a multidisciplinary follow-up framework
in children with bronchopulmonary dysplasia resulted in a significant reduction in hospital
readmissions.
Despite the burden of respiratory disease, moderate to late preterms do not currently receive
standardised respiratory follow-up care. With LONG LOVE, the investigators introduce a novel
follow-up framework tailored for preterms and designed to improve respiratory health. As the
risk of the onset of pulmonary disease is further increased by postnatal factors such as
tobacco smoke exposure, air pollution and RTI, our main focus is the detection and treatment
of these modifiable influencing factors. LONG LOVE incorporates eHealth and new technology in
order to measure pulmonary function and air quality. Intervention strategies include
counseling on nutrition, lifestyle, medication, and improving indoor air quality.
Objective of the study:
The project's overarching aim is to diminish respiratory disease burden in moderate-late
preterm born infants in their first 18 months of life.
The investigators have formulated the following specific objectives:
1. Determine whether the introduction of our follow-up framework will reduce the number
and/or severity of RTI and wheezing episodes in the first 18 months of life
2. Analyse the predictive value of nocturnal impedance pneumatography on lower respiratory
symptoms in prematurely born infants < 1 year of age. Further, correlate this novel tool
to other forms of pulmonary function analyses such as the Lung Clearance Index and
Hypoxic Challenge Test.
3. Conduct a cost-benefit analysis after the implementation of our framework.
Study design:
The investigators intend a quasi-experimental design based on a non-randomized cluster trial,
in which moderate-late preterm-born infants will be allocated to the intervention or control
group based on the location of birth. This design was chosen based on the limited amount of
participating clusters and feasibility. As a quasi-experimental design can result in
confounding by cluster and to increase internal validity, subjects of the control and
intervention groups will be demographically matched at baseline[54,55]
Cluster 1 Consists of participants born in Franciscus Gasthuis (FG) and/or Vlietland (FV) and
will be allocated to the intervention group, receiving additional (in addition to the current
standard of care) follow-up in accordance with our newly developed framework to identify
modifiable influencing factors compromising pulmonary health using validated questionnaires,
weekly monitoring of respiratory symptoms as reported by parents using an app, in- and
outdoor air quality measurements and non-invasive pulmonary function measurements based on
impedance pneumatography.
In case of any modifiable influencing factors, appropriate lifestyle and/or medical
interventions will be undertaken.
Cluster 2 (control) Consist of participants born in Maasstad Ziekenhuis (MSZ) and Albert
Schweitzer Ziekenhuis (ASZ) and will receive standard of care follow-up.
Parents are requested to provide informed consent for the registration of outcome
measurements and requested to complete validated questionnaires. Data on utilization of
medical services will be inquired to avoid recall bias.
Study population:
Moderate-late preterm infants (GA 30+0-35+6 weeks) without other significant underlying
syndromal, cardial, and/or pulmonal morbidities.
Intervention:
Follow-up regimen after premature birth using the LONG LOVE framework:
Identification of modifiable influencing factors Five study visits are scheduled to monitor
health status on 1-1.5*, 3, 6, 12 and 18 months of age. These visits are planned in
conjunction with regular follow-up examinations. Well-being and other potential risks will be
determined by: growth, nutritional problems, feeding mode, pets, maternal stress (Edinburgh
Postnatal Depression Scale questionnaire), sleep (Infant Sleep Questionnaire (ISQ)), tobacco
smoke exposure, daycare attendance, the existence of siblings.
Air quality measurements Outdoor air analysis will be obtained using national and regional
air measurement networks (RIVM Luchtmeetnet; DCMR Milieudienst Rijnmond). This network
consists of a large number of air quality measurement sites, measuring harmful substances:
nitric oxides (NOx, NO2), particulate matter (PM2.5, PM10), and ozone. Measurements will be
taken from a station located nearest to the home address of the participant. Measurements are
provided as publicly accessible data by the Dutch government.
Indoor air quality will be analyzed using a commercially available environment monitor. This
device offers real-time monitoring of air quality factors such as temperature, humidity,
particulate matter (PM1, PM2,5, PM10), carbon dioxide, and volatile organic compounds (VOCs).
Air quality measurements will be taken from the living room or participants' sleeping room
for a total duration of 1 year.
Pulmonary function analysis Pulmonary function analysis using impedance pneumatography will
be measured at 3, 6, and 12 months of age during two consecutive nights using the Ventica
recorder.
eHealth All parents are requested to install a newly developed application on their phones
when enrolled in the study. The app is used for a weekly evaluation of respiratory symptoms.
The following clinical parameters/variables will be monitored throughout the study:
Respiratory health will be determined as follows: physician-diagnosed lower RTI- and wheezing
episodes, hospitalizations for respiratory problems, clinical variables such as other
respiratory episodes, common colds, medication use (bronchodilators, corticosteroids,
antibiotics).
Interventions Aside from identification of potential health risks, our framework is designed
to offer interventions if required. At baseline, all participants receive verbal and written
information (App) defining potential hazardous factors regarding pulmonary development and
overall health. In the event of pulmonary symptoms, parents are requested to consult a
doctor.
In case of modifiable influencing factors, the following lifestyle and medical interventions
will be performed:
In the case of 1.5 SDS weight gain or loss (based on birth weight), nutritional advice is
provided by a paediatrician and follow-up by primary infant health care services.
In case of EPDS-scores ≥12 (stress-depression mother) consultation by lifestyle coach or
community worker (Kleine Heldenhuis). If required, referral to general practitioner or
psychologist/psychiatrist.
If sleep quality is affected (ISQ >12): medical advice and sleep training is provided by a
paediatrician and/or primary infant health care services In the case of pulmonary symptoms:
clinical assessment by a general practitioner or paediatrician. Administration of antibiotics
according to Dutch board of Paediatricians guideline, optionally C-reactive protein
measurement to prevent unnecessary antibiotics use If one or both caretakers are smoking:
consultation by a general practitioner and primary infant health care services to provide
stop-smoking services In case of inferior indoor air quality: visit by PhD-student or
pulmonary care nurse to instruct how to improve air quality Optimal identification and
treatment of comorbidity: gastro-oesophageal re ux disease, vitamin D deficiency, iron
deficiency anaemia by paediatrician Active consultancy and treatment of nasal congestion
using saline and-or xylometazoline by paediatrician Bronchodilator/broncholytic (salbutamol)
trial by pediatrician in event of recurrent clinical bronchial obstruction and/or abnormal
expiratory variability index using impedance pneumatography. If bronchodilator therapy is
regularly required (a minimum of 2 episodes 2-3 days of week for a minimal duration of two
weeks), inhaled corticosteroids can be prescribed.
These interventions are performed by both primary and secondary healthcare professionals
(including the PhD-student who has an active role in patient management). Primary infant
healthcare services operating in the Rijnmond region will fulfill an important role and are
directly involved with the implementation of this framework.
