Determine the existence of a relation between GER and apnea and their underlying mechanisms, in infants *37 weeks * 12 months.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Temporal relation between onset transient lower esophageal sphincter
relaxations (TLESR), onset of GER event, onset of GER reaching the pharynx (if
present), onset of cessation of nasal airflow, onset of cessation of
respiratory effort (if present), onset of deceleration of heart rate(if
present) and onset of desaturation(if present)
Secondary outcome
GERd complaints objectified through questionnaire parents
Background summary
Gastroesophageal reflux (GER) and apnea are two phenomena often seen in
infants. GER is the involuntary movement of gastric contents into the
esophagus. Pathologic GER (GER disease (GERD)) is defined as GER which causes
troublesome symptoms or complications. An apneai is a cessation of respiratory
air flow and might be central (no respiratory effort), obstructive (usually
upper airway obstruction) or mixed in nature. Pathological apnea is defined as
a cessation of breathing for >20 seconds, or a period of shorter duration
accompanied with significant desaturation, hypoxemia or bradycardia. Since GER
and apnea often coincide in infants, a causal relationship is commonly
proposed. Several theories suggest GER to be a causal factor in the generation
of both central and obstructive apnea*s, but vice versa apnea*s have been
suggested to cause GER as well. Finally, both breathing an GER are centrally
mediated in the same region of the brainstem and could thus both be the result
of a single vagally mediated central phenomenon. There is a substantial number
of studies conducted to assess these presumed relationships but no definite
conclusions can be drawn as yet. This is most likely the result of these
studies, being of poor methodological quality and lacking a complete evaluation
of gastroesophageal reflux and - function and/or evaluation of apnea.
A combined high-resolution manometry / high resolution multichannel
intraluminal impedance (HRM-MII) and complete polysomnography(PSG) is the most
sophisticated way to assess any relation between GER and apnea and their
underlying mechanisms.
Study objective
Determine the existence of a relation between GER and apnea and their
underlying mechanisms, in infants *37 weeks * 12 months.
Study design
prostpective, pathophysiological, observational study
Study burden and risks
All infants will undergo a combined HRM-MII for 6 hours during the 12 hour PSG
study. The usual 24 hour clinical GER measurement is completed as per PSG
protocol after the 6 hours, without the need of any additional hospital stay.
PSG recordings are non invasive and considered clinical necessary in the
included infants. Per clinical PSG protocol, a standard 24 hour combined pH-MII
measurement is included in the evaluation of the patient. For this purpose,
infants are intubated with a 6 french gastroesophageal catheter. For the
purpose of this study, this catheter will be replaced by a 6 french HRM-MII
catheter for the first 6 hours of the study. In our experience, this procedure
is well tolerated and causes only minor discomfort in infants. For correct
placement of the pH-MII catheter, a thorax X-ray is made during clinical PSG
studies. Our study catheter is able to exactly locate the position of the lower
esophageal sphincter relative to the nose, making this X-ray unnecessary. All
included patients will thus be spared radiation.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Informed consent signed by care-givers
*37wks * 12 months GA
Clinical suspicion of unexplained respiratory events, apneas and gastroesophageal reflux
Exclusion criteria
Previous gastro-intestinal (GI) surgery
Structural gastro intestinal abnormalities
Neurological Syndromes
Any condition that will make it unsafe the subject to participate.
medical treatment of GER and/or apneas < 3 days prior to study.
Any condition that will make discontinuation of medication impossible, as determined by the treating physician.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43264.018.13 |