Clinical trial NCT05484726: Maternal Role in Oral Feed Establishment in Preterm Neonates
Official title: Maternal Role in Sensory-motor Stimulation for Oral Feed Establishment in Preterm Neonates: MSMS Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Tube Feeding
Swallowing Disorder
Maternal Care Patterns
Keywords: Prematurity
sensory-motor stimulation
oral feed establishment
feeding intervention
Lead sponsor: Fatima Memorial Hospital
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 130
Sex: ALL
Minimum age (years): 30
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 1. Maternal involvement in perioral sensory-motor stimulation be in three stages

   1. Observer status
   2. Performing under supervision
   3. Independent
2. Intervention period: 5 days as

   1. Training phase (T): T1 and T2 (for mothers by the nurse)
   2. Direct feeding phase (D): F1, 2, and 3 (oral feed shall be offered to neonate)
3. Stimulation for 7 minutes and 15 minutes before feeding twice a day at 1100 and 1700 hrs.
4. Two groups

   1. Intervention group (GI): by mothers
   2. Control group (G II): by staff nurses
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hypothesis

Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will

1. Start taking oral feed at the same time as compared to control group
2. Take the same amount of milk at the commencement of oral feeding
3. Take milk with equal efficiency
4. Not face more adverse effects

Detailed description: Aim To determine the maternal role in sensory-motor stimulation for oral feed establishment in preterm neonates Objective

1. Determine the effect of sensory-motor stimulation offered by the mother on the onset of oral feeding
2. Efficiency of mother-mediated stimulation techniques on oral feeding as compared to trained nurses
3. Study maternal role in the establishment of oral feed Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will

1. Start taking oral feed at the same time frame as compared to the control group 2. Take the very same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. There is no extra burden of adverse effects

Data Collection All on going and related trials for this intervention shall be registered in the ClinicalTrials.gov. Study shall be conducted after ethical approval from IRB. All participants shall be enrolled after written informed consent from mothers after approval from attending neonatologist (annexure 2). All relevant maternal and neonatal data shall be collected on a specially designed proforma (annexure 3) with following details

1. Part 1: Maternal demographic and clinical data (age, parity, educational qualification, residence, previous preterm baby, job status, diabetes, hypertensive disorders, chronic ailment, multifetal gestation
2. Part 2: Neonatal demographic data (gender, gestation age, birth weight, growth centiles, diagnosis, APGAR score, noninvasive (NIV) and invasive ventilation with duration, caffeine, days taken for establishment of gavage feeding, age, and weight at commencement of intervention, any other complication during study)
3. Part 3: Neonatal feeding physiological measurements (SpO2, respiratory rate, heart rate before and after feeding, daily weight gain, type of milk offered)
4. Part 4: Oral feeding skill (OFS) assessment adapted from the model presented by Lau and Smith (p). All parameters shall be recorded twice a day for D1, D2, and D3 separately. It includes

   * Total volume prescribed (ml)
   * Total volume has taken during feeding (ml)
   * Volume has taken during the first 5 min of feeding (ml)
   * Duration of oral feeding (min)
   * Overall transfer (OT %) volume taken/total volume prescribed
   * Proficiency(PRO%) volume taken during the first 5 min/total volume prescribed
   * Rate of transfer (RT) ml/min
   * SSB (Suck Swallow Breaths) coordination
   * Adverse events (cough, fatigue)
   * According to this oral feeding ability can be classified into four levels depending upon the level of maturity in ascending order as follows:

     * Level 1: PRO \< 30% and RT \< 1.5 ml/min
     * Level 2: PRO \< 30% and RT ≥ 1.5 ml/min
     * Level 3: PRO ≥ 30% and RT \< 1.5 ml/min
     * Level 4: PRO ≥ 30% and RT ≥ 1.5 ml/min

Eligibility criteria: Inclusion Criteria:

* All preterm of gestation age 28 to 34weeks
* Haemodynamically stable
* Established full Gavage feed
* No respiratory distress
* No need for respiratory support except LFNC
* Do not receive any kind of analgesics

Exclusion Criteria:

* Syndromic babies /genetic disorders
* Haemodynamically unstable babies including IVH (grade III \& IV), hemodynamically significant PDA on treatment, NEC(stage III)
* Major malformations
* Cleft lip and palate
* Anemia requiring blood transfusion

Primary outcomes:
measure: Transition Time to Full Oral Feeding
timeFrame: Expected time of oral feed establishment
measure: Improvement (Change) in Efficiency in Oral Feed Establishment
timeFrame: For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14
measure: •Adverse Outcome Monitoring
timeFrame: Adverse events were noted on D1, D2,D3,D5,D7 and D14
measure: •Adverse Events Monitoring
timeFrame: Adverse events were noted on D1, D2,D3,D5,D7 and D14
Secondary outcomes:
measure: • Total Volume Taken During Each Feeding
timeFrame: It was noted on D1, D2, D3, D5, D7 and D14
measure: • Volume Taken During the First 5 Min of Feeding (ml) VT5
timeFrame: Volume taken during the first 5 min of feeding (ml) VT5 was measured on D1, D2, D3, D5, D7 and D14
measure: •Rate of Transfer (RT) ml/Min
timeFrame: RT was measured on D1, D2, D3, D5, D7 and D14
measure: • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed
timeFrame: OT was measured on D1, D2, D3, D5, D7 and D14
measure: • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed
timeFrame: PRO % was measured on D1, D2, D3, D5, D7 and D14
measure: • Neonates Feeding With SSB Coordination
timeFrame: It was measured on D1, D2, D3, D5, D7 and D14
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rafia Gul
state: Shadman
Study officials:
affiliation: Fatima Memorial Hospital
name: Rafia Gul, FCPS (Neo)
role: PRINCIPAL_INVESTIGATOR
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