Transient Tachypnea of the NewbornNCT07549945
Restricted Fluid Therapy for Newborn Breathing Problems
A study testing restricted fluid regimen and Standart fluid in people with Transient Tachypnea of the Newborn and Fluid Therapy, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Evidence suggests that increased intravascular and interstitial fluid load in neonates with transient tachypnea of the newborn (TTN) may delay the clearance of fetal alveolar fluid (FAF). Restricted fluid (RF) therapy may accelerated FAF clearance and improve outcomes in these infants. Read more about this study
- Who is it for?
- Ages 34 to 42 weeks
- Conditions the study is for
- Transient Tachypnea of the Newborn, Fluid Therapy
- What is being tested?
- restricted fluid regimen and Standart fluid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 31 Jul 2023
- 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 34 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates born at our hospital with a gestational age of ≥34⁰/⁷ weeks who were diagnosed with TTN were included in the study.
Who cannot join
- Infants with severe congenital anomalies, those who required intubation in the delivery room or upon admission to the NICU, infants born through meconium-stained amniotic fluid, perinatally asphyxiated infants, infants with suspected sepsis based on risk factors or clinical findings, and infants diagnosed with TTN who did not require NIV were not included from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hitit University Erol Olçok Training and Research Hospital
Çorum, Çorum, 19100
About this study
Official title: Eficacy and Safety of Restricted Fluid Therapy in Transient Tachypnea of the Newborn: A Randomized Controlled Study
Evidence suggests that increased intravascular and interstitial fluid load in neonates with transient tachypnea of the newborn (TTN) may delay the clearance of fetal alveolar fluid (FAF). Restricted fluid (RF) therapy may accelerated FAF clearance and improve outcomes in these infants.
Term and late preterm infants with TTN requiring nasal intermittent positive pressure ventilation (NIPPV) were randomized within first 2 hours after birth to receive either RF or standard fluid (SF) therapy. Primary outcomes were the duration of NIPPV and the day of discharge. Secondary outcomes included changes in weight, urine output, biochemical parameters, and monitoring of potential adverse effects.
Read the detailed description
Transient tachypnea of the new-born (TTN) is the most common cause of respiratory distress, in term and late preterm infants. The pathophysiological basis of the disease is the inadequate resorption of fetal alveolar fluid (FAF) during the perinatal period. Normally, 10-20 mL/kg of FAF that fills in the alveoli during the fetal period plays a critical role in the development of lungs and maintaining airway patency. An increase in catecholamine and glucocorticoid levels with the onset of birth activates amiloride-sensitive sodium channels and thus facilitates the clearing of FAF through sodium and water absorption. In cesarean sections performed before the onset of labor, insufficient elevation of stress hormones delays the clearance of FAF. This leads to the accumulation of fluid in the interstitial space, alveolar air trapping, and ultimately impaired gas exchange, resulting in the development of TTN symptoms.
TTN presents with tachypnea, grunting, nasal flaring, increase in anterior-posterior chest diameter, and mild hypoxia that start in the first hours following birth. The diagnosis is based on clinical findings and is supported by chest radiography findings. Most cases resolve within a few days with supportive treatment which includes intravenous fluid support, oxygen therapy, and/or non-invasive ventilation (NIV) support. However, some cases may be complicated by persistent pulmonary hypertension or air leakage (pneumothorax, pneumomediastinum) and which may require invasive ventilation support.
Although diuretics, dopamine, nebulized epinephrine and beta-2 agonists have been investigated in the treatment of TTN, current meta-analyses have not demonstrated strong evidence supporting the efficacy of these agents. Recent studies have demonstrated evidence of increased fluid overload in infants with TTN, such as elevated serum NT-proBNP levels and reduced left atrial reservoir strain. Based on this pathophysiological basis, a limited number of studies have evaluated the efficacy of restricted fluid (RF) therapy in TTN. These studies have reported that RF therapy is safe and may shorten the duration of NIV. However, due to very low certainty about the current evidence, RF therapy is not included in the literature as standard approach and the need for further randomized studies is emphasized. Therefore, in the present study, the investigators aimed to evaluate the efficacy and safety of RF therapy, which is a low-risk and feasible approach that may influence the clinical course of TTN.
- Conditions
- Transient Tachypnea of the Newborn, Fluid Therapy
- Being tested
- restricted fluid regimen, Standart fluid
- Keywords
- transient tachypnea of the newborn, restricted fluid therapy,, Noninvasive Ventilation
- Medical subject headings
- Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restricted fluid regimenProcedure or surgery
The total fluid volume administered on the first day was initiated at 50 mL/kg/day in the RF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks. 40 mL/kg/day in gestational age of ≥37 weeks
Standart fluidProcedure or surgery
70 mL/kg/day in the standart fluid group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks, whereas it was initiated at 60 mL/kg/day in thestandart fluid group for infants with a gestational age of ≥37 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Restricted Fluid | Experimental | The total fluid volume administered on the first day was initiated at 50 mL/kg/day in the RF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks.
The total fluid volume administered on the first day was initiated at 40 mL/kg/day in the RF group for infants with agestational age of ≥37 weeks Receives: Procedure: restricted fluid regimen |
| Standart Fluid | Active comparator | The total fluid volume administered on the first day was initiated at 70 mL/kg/day in the RF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks.
60 mL/kg/day in gestational age of ≥37 weeks Receives: Procedure: Standart fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
Primary outcomes included duration of NIPPV
Measured: "From enrollment to the end of treatment at 3 mounts"
Primary Outcome
Discharge day,
Measured: From enrollment to the end of treatment at 3 mounts
Secondary outcomes (3)
secondary outcome
Changes in body weight in the following days
Measured: "From enrollment to the end of treatment at 8 weeks"
Secondary Outcome
Daily urine output (ml/kg/day) in the following days
Measured: from the time of recording to 7 days postnatal
Secondary outcome
Hypoglycemia monitoring (<50 mg/dL)
Measured: From enrollment to the end of treatment at 1 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Oct 2021
- Primary completion30 May 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Transient Tachypnea of the NewbornStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Infants with TTN requiring NIPPV were randomized within the first two hours of life to either the RF group or the standard fluid (SF) group using the sealed opaque envelope method. To ensure homogeneous distribution of infants with similar gestational ages between the groups, infants born at 34⁰/₇-36⁶/₇ weeks and those born at ≥37 weeks of gestation were randomized separately using a stratified randomization approach. The total fluid volume administered on the first day was initiated at 50 mL/kg/day in the RF group and 70 mL/kg/day in the SF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks, whereas it was initiated at 40 mL/kg/day in the RF group and 60 mL/kg/day in the SF group for infants with a gestational age of ≥37 weeks.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail Kürşad Gökçe, Hitit University
- Investigators
- İsmail K Gökçe, Assoc.prof, Principal investigator, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549945
- Sponsor's protocol ID
- Elif1453!
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta N, Bruschettini M, Chawla D. Fluid restriction in the management of transient tachypnea of the newborn. Cochrane Database Syst Rev. 2021 Feb 18;2(2):CD011466. doi: 10.1002/14651858.CD011466.pub2.
PubMed 33599990Sardar S, Pal S, Mishra R. A randomized controlled trial of restricted versus standard fluid management in late preterm and term infants with transient tachypnea of the newborn. J Neonatal Perinatal Med. 2020;13(4):477-487. doi: 10.3233/NPM-190400.
PubMed 32444567Dehdashtian M, Aramesh MR, Melekian A, Aletayeb MH, Ghaemmaghami A. Restricted versus Standard Maintenance Fluid Volume in Management of Transient Tachypnea of Newborn: A Clinical Trial. Iran J Pediatr. 2014 Oct;24(5):575-80. Epub 2014 Oct 1.
PubMed 25793064Stroustrup A, Trasande L, Holzman IR. Randomized controlled trial of restrictive fluid management in transient tachypnea of the newborn. J Pediatr. 2012 Jan;160(1):38-43.e1. doi: 10.1016/j.jpeds.2011.06.027. Epub 2011 Aug 11.
PubMed 21839467Gokce IK, Turgut H, Kaya H, Deveci MF, Alagoz M, Ozdemir R. Eficacy and safety of restricted fluid therapy in transient tachypnea of the newborn: a randomized controlled study. BMC Pediatr. 2026 Jul 8. doi: 10.1186/s12887-026-07303-6. Online ahead of print.
PubMed 42420914
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eficacy and Safety of Restricted Fluid Therapy in Transient Tachypnea of the Newborn: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07549945
- Acronym / sponsor ID
- Elif1453!
- Conditions
- Transient Tachypnea of the Newborn, Fluid Therapy
- Keywords
- transient tachypnea of the newborn, restricted fluid therapy,, Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 24 Apr 2026 (actual)
- 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.
Evidence suggests that increased intravascular and interstitial fluid load in neonates with transient tachypnea of the newborn (TTN) may delay the clearance of fetal alveolar fluid (FAF). Restricted fluid (RF) therapy may accelerated FAF clearance and improve outcomes in these infants.
Term and late preterm infants with TTN requiring nasal intermittent positive pressure ventilation (NIPPV) were randomized within first 2 hours after birth to receive either RF or standard fluid (SF) therapy. Primary outcomes were the duration of NIPPV and the day of discharge. Secondary outcomes included changes in weight, urine output, biochemical parameters, and monitoring of potential adverse effects.
Detailed description
Transient tachypnea of the new-born (TTN) is the most common cause of respiratory distress, in term and late preterm infants. The pathophysiological basis of the disease is the inadequate resorption of fetal alveolar fluid (FAF) during the perinatal period. Normally, 10-20 mL/kg of FAF that fills in the alveoli during the fetal period plays a critical role in the development of lungs and maintaining airway patency. An increase in catecholamine and glucocorticoid levels with the onset of birth activates amiloride-sensitive sodium channels and thus facilitates the clearing of FAF through sodium and water absorption. In cesarean sections performed before the onset of labor, insufficient elevation of stress hormones delays the clearance of FAF. This leads to the accumulation of fluid in the interstitial space, alveolar air trapping, and ultimately impaired gas exchange, resulting in the development of TTN symptoms.
TTN presents with tachypnea, grunting, nasal flaring, increase in anterior-posterior chest diameter, and mild hypoxia that start in the first hours following birth. The diagnosis is based on clinical findings and is supported by chest radiography findings. Most cases resolve within a few days with supportive treatment which includes intravenous fluid support, oxygen therapy, and/or non-invasive ventilation (NIV) support. However, some cases may be complicated by persistent pulmonary hypertension or air leakage (pneumothorax, pneumomediastinum) and which may require invasive ventilation support.
Although diuretics, dopamine, nebulized epinephrine and beta-2 agonists have been investigated in the treatment of TTN, current meta-analyses have not demonstrated strong evidence supporting the efficacy of these agents. Recent studies have demonstrated evidence of increased fluid overload in infants with TTN, such as elevated serum NT-proBNP levels and reduced left atrial reservoir strain. Based on this pathophysiological basis, a limited number of studies have evaluated the efficacy of restricted fluid (RF) therapy in TTN. These studies have reported that RF therapy is safe and may shorten the duration of NIV. However, due to very low certainty about the current evidence, RF therapy is not included in the literature as standard approach and the need for further randomized studies is emphasized. Therefore, in the present study, the investigators aimed to evaluate the efficacy and safety of RF therapy, which is a low-risk and feasible approach that may influence the clinical course of TTN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Infants with TTN requiring NIPPV were randomized within the first two hours of life to either the RF group or the standard fluid (SF) group using the sealed opaque envelope method. To ensure homogeneous distribution of infants with similar gestational ages between the groups, infants born at 34⁰/₇-36⁶/₇ weeks and those born at ≥37 weeks of gestation were randomized separately using a stratified randomization approach. The total fluid volume administered on the first day was initiated at 50 mL/kg/day in the RF group and 70 mL/kg/day in the SF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks, whereas it was initiated at 40 mL/kg/day in the RF group and 60 mL/kg/day in the SF group for infants with a gestational age of ≥37 weeks.
| Arm | Type | Receives |
|---|---|---|
| Restricted Fluid | Experimental | Procedure: restricted fluid regimenThe total fluid volume administered on the first day was initiated at 50 mL/kg/day in the RF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks. The total fluid volume administered on the first day was initiated at 40 mL/kg/day in the RF group for infants with agestational age of ≥37 weeks |
| Standart Fluid | Active comparator | Procedure: Standart fluidThe total fluid volume administered on the first day was initiated at 70 mL/kg/day in the RF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks. 60 mL/kg/day in gestational age of ≥37 weeks |
Who may qualify
- Ages
- 34 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates born at our hospital with a gestational age of ≥34⁰/⁷ weeks who were diagnosed with TTN were included in the study.
Key exclusion criteria (1 listed)
- Infants with severe congenital anomalies, those who required intubation in the delivery room or upon admission to the NICU, infants born through meconium-stained amniotic fluid, perinatally asphyxiated infants, infants with suspected sepsis based on risk factors or clinical findings, and infants diagnosed with TTN who did not require NIV were not included from the study.
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 |
|---|---|---|
| restricted fluid regimenThe total fluid volume administered on the first day was initiated at 50 mL/kg/day in the RF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks. 40 mL/kg/day in gestational age of ≥37 weeks | Procedure or surgery | Restricted Fluid |
| Standart fluid70 mL/kg/day in the standart fluid group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks, whereas it was initiated at 60 mL/kg/day in thestandart fluid group for infants with a gestational age of ≥37 weeks. | Procedure or surgery | Standart Fluid |
Primary outcome
primary outcome
Time frame: "From enrollment to the end of treatment at 3 mounts"
Primary outcomes included duration of NIPPV
Primary Outcome
Time frame: From enrollment to the end of treatment at 3 mounts
Discharge day,
3 secondary outcomes
secondary outcome
Time frame: "From enrollment to the end of treatment at 8 weeks"
Secondary Outcome
Time frame: from the time of recording to 7 days postnatal
Secondary outcome
Time frame: From enrollment to the end of treatment at 1 weeks"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 33599990Gupta N, Bruschettini M, Chawla D. Fluid restriction in the management of transient tachypnea of the newborn. Cochrane Database Syst Rev. 2021 Feb 18;2(2):CD011466. doi: 10.1002/14651858.CD011466.pub2.
- Background: PubMed 32444567Sardar S, Pal S, Mishra R. A randomized controlled trial of restricted versus standard fluid management in late preterm and term infants with transient tachypnea of the newborn. J Neonatal Perinatal Med. 2020;13(4):477-487. doi: 10.3233/NPM-190400.
- Background: PubMed 25793064Dehdashtian M, Aramesh MR, Melekian A, Aletayeb MH, Ghaemmaghami A. Restricted versus Standard Maintenance Fluid Volume in Management of Transient Tachypnea of Newborn: A Clinical Trial. Iran J Pediatr. 2014 Oct;24(5):575-80. Epub 2014 Oct 1.
- Background: PubMed 21839467Stroustrup A, Trasande L, Holzman IR. Randomized controlled trial of restrictive fluid management in transient tachypnea of the newborn. J Pediatr. 2012 Jan;160(1):38-43.e1. doi: 10.1016/j.jpeds.2011.06.027. Epub 2011 Aug 11.
- Derived from this study: PubMed 42420914Gokce IK, Turgut H, Kaya H, Deveci MF, Alagoz M, Ozdemir R. Eficacy and safety of restricted fluid therapy in transient tachypnea of the newborn: a randomized controlled study. BMC Pediatr. 2026 Jul 8. doi: 10.1186/s12887-026-07303-6. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
İsmail K Gökçe, Assoc.prof principal investigator
Hitit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restricted fluid regimen and Standart fluid in people with Transient Tachypnea of the Newborn and Fluid Therapy, run by Hitit University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
primary outcome (time frame: "From enrollment to the end of treatment at 3 mounts"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07549945, which also lists 5 linked publications.
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 24 Apr 2026.